Adverse Events Associated With 3 Vitrectomy Platforms Reported to the US FDA MAUDE Database.

Purpose: To identify and describe adverse events (AEs) observed with real-world use of the following 3 vitrectomy platforms: Constellation (Alcon), Enhancing Visual Acuity (EVA, Dutch Ophthalmic Research Center), and Stellaris (Bausch + Lomb). Methods: All reports submitted to the US Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database between January 2010 and November 2021 that were associated with the 3 vitrectomy platforms were analyzed. Each report was reviewed for AEs or consequences and the type of complication noted. Duplicates and reports with an inadequate narrative to categorize the event were excluded. A descriptive analysis was performed for the prevalence of device-specific issues within each platform. Results: The analysis included 2534 reports (1738 Constellation, 117 EVA, 679 Stellaris). Overall, the most commonly reported complications involved the vitrectomy probe (n = 957 [37.8%]) and the central processing unit (n = 368 [14.5%]). Differences in the distribution of AEs among the platforms were noted, with vitrectomy probe issues being the most reported events for the Constellation and Stellaris and infusion issues for the EVA. Infusion issues most frequently led to reports of patient harm with the Constellation (31/1738 [1.8%]) and EVA (7/116 [6.0%]), while issues with the vitrectomy probe were reported with the Stellaris (11/679 [1.6%]). Conclusions: An analysis of real-world data in the MAUDE database highlighted the spectrum of device-specific AEs of greatest relevance to surgical practice. Familiarity with potential device complications will help minimize harm to patients.

Adverse events related to robotic-assisted knee arthroplasty: a cross-sectional study from the MAUDE database.

BACKGROUND: Robotic-assisted surgical technique has been clinically available for decades, yet real-world adverse events (AEs) and complications associated with primary knee arthroplasty remain unclear. METHODS: In March 2023, we searched the FDA website and extracted AEs related to robotic assisted knee arthroplasty (RAKA) from the MAUDE database over the past 10 years. The "Brand Name" function queried major robotic platforms, including active and semi-active systems. The overall incidence of AEs was estimated based on annual surgical volume from the current American Joint Replacement Registry (AJRR). Two authors independently collected data on event date, event type, device problem, and patient problem. RESULTS: Of 839 eligible reports, device malfunction comprised mechanical failure (343/839, 40.88%) and software failure (261/839, 31.11%). For surgical complications, inappropriate bone resection (115/839, 13.71%) was most frequent, followed by bone/soft tissue damage (83/839, 9.89%). Notably, over-resection exceeding 2 mm (88/839, 10.49%), joint infection (25/839, 2.98%), and aseptic loosening (1/839, 0.12%) were major complications. Only two track pins related AEs were found. Moreover, the distribution of these AEs differed substantially between robot manufacturers. According to the AEs volume and AJRR data, the overall incidences of AEs related to RAKAs were calculated with 0.83% (839/100,892) between November 2010 and March 2023. CONCLUSION: Our analysis shows that while reported AEs might be increasing for RAKAs, the overall rate remains relatively low. Reassuringly, device malfunction was the most commonly AEs observed, with a minor impact on postoperative outcomes. Furthermore, our data provide a benchmark for patients, surgeons, and manufacturers to evaluate RAKA performance, though continued improvement in reducing serious AEs incidence is warranted.

Trends and incidence of reported events associated with ureteral stents: an analysis of the food and drug administration's manufacturer and user facility device experience (MAUDE) database.

PURPOSE: Aim of this study is to summarize medical device reports (MDRs) between 2012 and 2022 relating to ureteral stents within the Manufacturer and User Facility Device Experience (MAUDE) database maintained by The Food and Drug Administration (FDA). METHODS: MAUDE was analyzed for all MDRs relating to each FDA-approved ureteral stent. Event descriptions were reviewed and characterized into specific event types. Outcome measures include specific ureteral stent and reported events as detailed by the MDRs. Data is presented as number of specific event/total events. Pooled Relative risk was used to compare data. RESULTS: 2652 reports were retrieved in 10 years and a progressive rise in reported events was recorded. 831/2652 (31%) were reported as injury while 1810/2652 (68%) as malfunction of the ureteral stent and 4 events of death. The most frequently reported adverse events (AEs) were stent break (627/2652: 23%); material problems (384/2652: 14%); calcification (222/2652: 8%); difficulty to insert, advance or remove the device (155/2652: 6%). Bard stents were associated with most material problems (19%), Resonance stents were associated with most difficulty to insert, advance or remove the device (9%) and calcification (15%) while filiform double pigtail stent set were associated with most breakage reports (56%) when compared to the other stents (PRR > 1, p < 0,05). CONCLUSIONS: According to MAUDE database the most frequent complications related to ureteral stents are breakage, material problems, calcification and difficulty to insert/advance/remove the device. As well Resonance ureteral stents seem to be associated with a higher risk of device problems.

A Comprehensive Analysis of Reported Adverse Events and Device Failures Associated with Esophageal Self-Expandable Metal Stents: An FDA MAUDE Database Study.

INTRODUCTION: Esophageal Stents are used to maintain esophageal lumen patency in esophageal strictures caused by intrinsic and/or extrinsic malignancies and the occlusion of concomitant esophageal fistulas. While data on the efficacy and safety of esophageal stents exist, comprehensive evaluation of adverse events is limited. The aim of this study is to investigate the reported adverse events and device failures associated with esophageal self-expandable metal stents (SEMS) using the FDA's Manufacturer and User Facility Device Experience (MAUDE) database. METHODS: Post-marketing surveillance data for the esophageal SEMSs were analyzed using the FDA's MAUDE database from January 2014 to December 10, 2023. The outcomes of interest were patient-related adverse events and device failures. Statistical analysis was performed using Microsoft Excel 2010 and SPSS. Pooled numbers and percentages were calculated for each adverse event. Continuous variables underwent analysis using a two-tailed student t test, and significance was set to p ≤ 0.05. RESULTS: During the study period, 548 MAUDE reports revealed 873 device failures and 186 patient-related adverse events. The most common device issues were stent activation, positioning, or separation problems (4 n = 403; 46.2%), followed by device detachment or migration (n = 109, 12.5%), and material problems (n = 93, 10.7%). Patient complications included dysphagia/odynophagia (10%), perforation, pain, and bleeding (each 7.6%). The most common device failures in over-the-wire (OTW) stents and through-the-scope (TTS) stents were activation, positioning, or separation problems (TTS: n = 183, 52.6% vs OTW: n = 220, 41.9%). Compared to OTW stents, TTS stents had higher migration and breakage (13.5% vs. 11.8%, p = 0.24), and (9.2% vs. 6.7%, p = 0.08) respectively, while OTW stents had more challenges with stent advancement or removal (5.1% vs. 0.3%, p < 0.001 and 4.6% vs 3.4%, p = 0.19, respectively) and material problems (14.7% vs. 4.6%, p < 0.001). Activation, positioning, and separation problems were the most frequent device failures in fully covered (FC) and partially covered (PC) stents (FC: n = 62, 32.8%, PC: n = 168, 43.5%). FC stents had higher migration rates (20.6% vs 9.8%, p < 0.001), while PC stents exhibited more material problems (17.4% vs. 5.8%, p < 0.001) and difficulties with advancing the stents (6.7% vs. 0%, p < 0.001). CONCLUSION: Our examination showed a prevalence of reported device complications associated with stent activation, positioning, and separation problems. Dysphagia or odynophagia emerged as the most frequently reported patient complication. Furthermore, our analysis, provides insights into TTS vs. OTW and FC vs. PC esophageal SEMSs, enabling endoscopists and manufacturers to better understand adverse events and potentially optimize device design for future iterations.

Adverse Events and Device Failures Associated with Pancreatic Stents: A Comprehensive Analysis Using the FDA's MAUDE Database.

INTRODUCTION: Pancreatic duct stents (PDS) are widely used for the prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis. However, there is a paucity of data regarding the adverse events associated with PDS placement. This study aims to investigate the reported adverse events and device failures related to PDS, utilizing the Manufacturer and User Facility Device Experience (MAUDE) database maintained by the U.S. Food and Drug Administration (FDA). METHODS: Post-marketing surveillance data from January 2013 to December 8, 2023, were extracted from the FDA's MAUDE database to analyze the reports pertaining to the use of commonly used PDS. The primary outcomes of interest were device issues and patient-related adverse events. Statistical analysis was performed using Microsoft Excel 2010, with the calculation of pooled numbers and percentages for each device and patient adverse event. RESULTS: A total of 579 device issues and 194 patient-related adverse events were identified. Device issues were primarily attributed to stent deformation (n = 72; 12.4%), followed by migration of the device into the pancreatic duct or expulsion out of the duct (n = 60; 10.4%), and stent fracture/breakage (n = 55; 9.4%). Among the patient-reported adverse events, inflammation was the most common (n = 26; 13.4%), followed by reports of stents becoming embedded in tissue (n = 21; 10.8%) and stent occlusion/obstruction (n = 16; 8.2%). The most prevalent device failures associated with Advanix stents were material deformation, with perforation (n = 3, 30%) being the most frequently reported adverse event. Concerning Geenen stents, migration or expulsion of the device (n = 34, 16.9%) constituted the most common device-related adverse events, while inflammation (n = 20, 16.7%) was the most frequently reported patient-related issue. For Zimmon stents, migration or expulsion of the device (n = 22, 8.8%) were the most frequently reported device-related problems, whereas perforation (n = 7, 10.9%) and bleeding (n = 7, 10.9%) were the most frequent patient-related adverse events. CONCLUSION: Our findings highlight important device and patient adverse events that endoscopists and referring providers should be aware of before considering pancreatic stent placement.

Nasal Epistaxis Balloons: A Comprehensive MAUDE Database Analysis.

BACKGROUND: While nasal epistaxis balloons are generally seen as safe and routinely utilized by both surgical and nonsurgical providers, the complication profile related to this type of device has not been well defined. OBJECTIVE: The objective of this study was to utilize the FDA MAUDE (Manufacturer and User Facility Device Experience) database to better assess adverse events (AE) related to use of nasal epistaxis balloons. Reports were individually tabulated and events were categorized with special attention to AEs. METHODS: The FDA MAUDE database was queried for all medical device reports (MDR) related to nasal epistaxis balloon devices from January 2012 to November 2022. RESULTS: 19 MDRs met inclusion criteria. 5 MDRs were classified as device related (26.3 %); two events were reported for balloon leak and deflation, two events were reported for device breakage, and one device related event was unknown. 14 MDRs (73.7 %) were classified as patient related. Two documented MDRs were patient deaths due to exsanguination. Additional serious AEs included balloon ingestion and subsequent small bowel perforation (n = 1), cerebrospinal fluid leak (n = 1), skull base violation and intracranial placement of the device (n = 1), and respiratory distress (n = 3). CONCLUSION: Though epistaxis control with nasal balloons is generally seen as a safe procedure, there have been several concerning AEs reported. While two reports of death due to exsanguination were the most severe AEs, multiple other life-threatening AEs were also documented. Increased awareness of associated complications can be used to better counsel patients during the informed consent process as well as providers in their clinical decision making.

Complications of eustachian tube balloon dilation: Manufacturer and User Facility Device Experience (MAUDE) database analysis and literature review.

Objective: To provide an analysis of complications following eustachian tube balloon dilation as well as their treatments and outcomes. Data Sources: PubMed, Ovid Embase, and MAUDE Database. Review Methods: A systematic approach following PRISMA guidelines was used to identify publications pertaining to balloon dilation of the eustachian tube from PubMed and Ovid Embase databases was used. Once these publications were critically reviewed, the primary outcome extracted were reported complications. Additional complications were collected in the Manufacturer and User Facility Device Experience (MAUDE) database using the product class "eustachian tube dilation device" and searching through relevant manufacturers. Complications and outcomes were compared between these sources. Results: Fifty five full-length manuscripts involving 7155 patients were included and 98 complications reported for a 1.4% complication rate. The most frequently reported adverse events were subcutaneous emphysema of the head and neck (19%), epistaxis (12%), and acute otitis media (11%). The MAUDE search returned 18 distinct patient entries, of which 12 (67%) reported complications. The most reported complications in the MAUDE database included subcutaneous emphysema (8, 67%) and pneumomediastinum (3, 25%). The most serious complication was a carotid artery dissection reported in one patient in the MAUDE database. Conclusion: Eustachian tube dilation is rarely associated with complications, which nevertheless may lead to morbidity and medical emergencies. Patients and providers should recognize potential risks associated with this intervention as well as methods to manage complications.

Eustachian Tube Balloon Dilation: A Comprehensive Analysis of Adverse Events.

BACKGROUND: Eustachian tube balloon dilation (ETBD) has been Food and Drug Administration (FDA) approved for refractory Eustachian tube dysfunction since 2016. While ETBD is generally seen as safe, the complication profile has not been well defined. OBJECTIVE: The objective of this study was to utilize the FDA manufacturer and user facility device experience (MAUDE) database to better assess adverse events (AE) related to ETBD. METHODS: This is a study of a multiinstitutional database maintained by the U.S. FDA. A database analysis was performed via the collaboration of multiple clinicians at tertiary referral centers. The FDA MAUDE database was queried for all medical device reports (MDR) related to ETBD devices from January 2012 to November 2022. Eighty-eight unique MDR were identified, 16 of which met inclusion criteria. RESULTS: Three MDRs were classified as device-related (18.8%); none resulted in an AE. Thirteen MDRs (81.3%) were patient-related; all were classified as AEs. The most common AE was postoperative subcutaneous emphysema (n = 6, 46.2%). Of the patients with subcutaneous emphysema, there was a wide range of severity. The most severe AE (n = 1, 6.3%) was postoperative stroke secondary to carotid artery dissection. CONCLUSION: Though ETBD is generally seen as a safe procedure, there have been several concerning AEs reported to date. Increased awareness of ETBD complications can serve as a primer for improved patient education and counseling during the informed consent process and aid surgeons in clinical decision-making. Future studies with standardized reporting protocols are warranted to create a central registry for ETBD.

Analysis of Reported Adverse Events Associated with Over-the-Scope Endoscopic Suturing System: an FDA MAUDE Database Study.

PURPOSE: The over-the-scope endoscopic suturing system (ESS) (OverStitch™) is one of the most widely utilized endoscopic suturing systems in current clinical practice; however, data on the adverse events associated with this device is scarce. Our study aims to evaluate the adverse events and complications associated with the over-the-scope ESS using the FDA's Manufacturer and User Facility Device Experience (MAUDE) database. MATERIALS AND METHODS: We analyzed the post-marketing surveillance data from the FDA MAUDE database for the over-the-scope ESS from January 2008 through June 2022. RESULTS: Eighty-three reports were filed from January 2008 to June 2022. Adverse events were classified as device-related complications and patient-related adverse events. Seventy-seven device-related issues and 87 patient adverse events were identified. The most common device-related issue was difficulty to remove after deployment (n=12, 15.58%) followed by mechanical problem (n=10, 12.99%), mechanical jam (n=9, 11.69%), or entrapment of device (n=9, 11.69%). Of the 87 patient-related adverse events, the most common was perforation (n=19; 21.84%), followed by device embedded in tissue or plaque (n=10; 11.49%), and abdominal pain (n=8; 9.20%). Of the 19 patients who experienced perforation, two required open surgical repair and one required laparoscopic surgical repair. CONCLUSION: The overall adverse events from the over-the-scope ESS remain acceptable as evidenced by the number of reported cases since 2008. However, it is important to note that adverse event rates might increase as the use of the device increases; therefore, it is essential for endoscopists to be aware of the potential common and rare adverse events associated with the use of the over-the-scope ESS device.

Analysis of "Multicenter Evaluation Study Comparing a New Factory-Calibrated Real-Time Continuous Glucose Monitoring System to Existing Flash Glucose Monitoring System".

In an article in the Journal of Diabetes Science and Technology, Ji et al. report on the accuracy of a new factory calibrated continuous glucose monitoring system, the AiDEX CGM (Microtech Medical Company, Ltd., Hangzhou, China). This is the first report from a new manufacturer of a highly accurate factory calibrated CGM. The authors report that the accuracy of the AiDEX CGM is comparable to previous results from Abbott Diabetes Care and Dexcom. However, the study protocol was significantly different from previous studies. This study is the first of numerous studies likely from other manufacturers of CGM technology. It raises the question of how to evaluate sensor performance in the coming era of mass adoption of CGM and increased use of automated insulin delivery systems.

Analysis of ventilator fatal adverse events in FDA MAUDE database / 医疗卫生装备

The data on reported adverse events of ventilators in the U.S.Food and Drug Administration(FDA)Medical Device Manufacturer and User Facility Device Experience(MAUDE)database were searched from January 1,2022 to December 31,2022,of which the data on ventilator fatal adverse events were extracted and statistically analyzed with Python.The main causes for ventilator fatal adverse events were pointed out including degradation of noise-reducing foams,improper use and ventilator malfunction,and some suggestions were put forward accordingly from the aspects of material,manufacturer,user,maintainer and supervisor.References were provided for utilization management and adverse events control for other medical devices.[Chinese Medical Equipment Journal,2023,44(10):86-90]

Adverse Events Related to Cartiva Hemiarthroplasty of First Metatarsal: An Analysis of Reports to the United States Food and Drug Administration.

Background: The results supporting Cartiva, a synthetic cartilage implant (Wright Medical) in hallux rigidus have come from limited institutions creating observational bias. Complications experienced in community centers are not routinely included in the published literature. To look at a broader range of potential complications, we reviewed the United States Food and Drug Administration's (FDA) voluntary device database and compared that data with published literature. Methods: The Manufacturer and User Facility Device Experience (MAUDE) database of the FDA was retrospectively reviewed between July 2016 and October 2019 using the product code: PNW, assigned for Cartiva. Results: A total of 49 events have been reported and implant subsidence was the most common with 16 reports. Others include fragmentation (9), infection (4), bone erosion (3), foreign body reaction (1) and unspecified (16). Thirty-five events mentioned further surgeries at a mean interval of 4.75 months. Conclusions: The analysis of the MAUDE database disclosed certain device-related dysfunctions that have been underreported in the published literature. Because of the voluntary nature of reporting, the true incidence of each complication is unknown with this data representing a baseline. The MAUDE database could be further strengthened by a more robust reporting mechanism or mandatory reporting of device-related complications.Levels of Evidence: Level IV: Case series from large database analysis.

Real world adverse events of interspinous spacers using Manufacturer and User Facility Device Experience data.

BACKGROUND: Lumbar spinal stenosis is a condition of progressive neurogenic claudication that can be managed with lumbar decompression surgery or less invasive interspinous process devices after failed conservative therapy. Popular interspinous process spacers include X-Stop, Vertiflex and Coflex, with X-Stop being taken off market due to its adverse events profile. METHODS: A disproportionality analysis was conducted to determine whether a statistically significant signal exists in the three interspinous spacers and the reported adverse events using the Manufacturer and User Facility Device Experience (MAUDE) database maintained by the US Food and Drug Administration. RESULTS: Statistically significant signals were found with each of the three interspinous spacer devices (Coflex, Vertiflex, and X-Stop) and each of the following adverse events: fracture, migration, and pain/worsening symptoms. CONCLUSIONS: Further studies such as randomized controlled trials are needed to validate the findings.

Adverse events related to total ankle replacement devices: an analysis of reports to the United States Food and Drug Administration.

BACKGROUND: The published outcomes of total ankle replacement (TAR) implants came from limited institutions creating observational bias. For broader perspective, we queried the Food and Drug Administration's (FDA) Manufacturer and User Facility Device Experience (MAUDE) voluntary database to explore complications reported outside published literature. METHODS: The database was reviewed retrospectively between November 2011 and April 2019 using two product codes assigned to six TAR devices. RESULTS: Among 648 relevant reports available in the database, common complications were aseptic loosening (19.3%), infection (18.2%), and alignment/mechanical issues (16.5%). Others included instrument/instrumentation complications, impingement, polyethylene problems, fractures, avascular necrosis of talus (AVN), and packaging issues. CONCLUSION: MAUDE database revealed various patterns of device-related malfunctions that have been under-reported in published data. Despite inconsistency in the available reports, it provided opportunities for improvements in quality control, device design, and ultimately patient safety. Database would be further strengthened by more robust reporting mechanism or mandatory reporting of device-related complications.

Adverse events involving hallux metatarsophalangeal joint implants: Analysis of the United States Food and Drug Administration data from 2010 to 2018.

BACKGROUND: The prevalence of osteoarthritis of the hallux metatarsophalangeal joint (MTPJ) is 1 in 40 people over the age of 50. Surgical treatment options for MTPJ arthritis include joint preservation, joint resurfacing, and arthrodesis. Hallux MTPJ implants have evolved over the past several decades, but are associated with various complications. The aim of this study was to examine the MAUDE database to determine reported adverse events for hallux MTPJ implants. MATERIALS AND METHODS: The US Food and Drug Administration's (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was reviewed from 2010 to 2018 to review voluntary reported adverse event reports for approved implants within the United States. We recorded the type of adverse event and excluded duplicate reports and those extracted from already published literature. RESULTS: Among 64 reported hallux MTPJ implant adverse events, the most common modes of adverse events were component loosening (34%), infection (14.1%), component fracture (9.4%), inflammation (9.4%), and allergic reaction (7.8%). Regarding implant type, Cartiva SCI had the highest percentage of adverse events (23.4%), followed by Arthrosurface ToeMotion (20.3%), Ascension MGT (12.5%), Arthrosurface HemiCAP® (10.9%), Futura primus (9.4%), and Osteomed Reflexion (6.3%). There was an increase in reported adverse events after 2016. The MAUDE database does not report the total incidence of implant insertion. CONCLUSION: Our study of the MAUDE database demonstrated that component loosening and infection are the most common modes of adverse events for hallux MTPJ implants. Cartiva accounted for one-fourth of the implant-related adverse events during our study period, followed by ToeMotion, and Ascension MGT implants. Continued reporting of adverse events will improve our understanding on short and long-term complications of various hallux MTPJ implants. LEVEL OF EVIDENCE: Level IV; Case Series from Large Database Analysis; Treatment Study.

MRI-related FDA adverse event reports: A 10-yr review.

PURPOSE: To provide an overview of the types of adverse events reported to the US Food and Drug Administration (US FDA) for magnetic resonance (MR) systems over a 10-yr period. METHODS: Two reviewers independently reviewed adverse events reported to FDA for MR systems from 1 January 2008 to 31 December 2017 and manually categorized events into eight event types. Thermal events were further subcategorized by probable cause. Objects that became projectiles were also categorized. RESULTS: FDA received 1568 adverse event reports for MR systems between 1 January 2008 and 31 December 2017. This analysis included 1548 reports. Thermal events were the most commonly reported serious injury (59% of analyzed reports). Mechanical events - defined as slips, falls, crush injuries, broken bones, and cuts; musculoskeletal injuries from lifting or movement of the device - (11%), projectile events (9%), and acoustic events (6%) were also observed. CONCLUSIONS: Adverse events related to MR systems consistent with the known hazards of the MR environment continue to be reported to FDA. Increased awareness of the types of adverse events occurring for MR imaging systems is important for prevention.

Major Complications and Adverse Events Related to the Injection of the SpaceOAR Hydrogel System Before Radiotherapy for Prostate Cancer: Review of the Manufacturer and User Facility Device Experience Database.

Purpose: SpaceOAR® is a Food and Drug Administration-approved hydrogel injection used to create space between the prostate and rectum during prostate radiotherapy. It has shown to significantly reduce the rectal radiation dose with lower rates of rectal toxicity. Despite a high safety performance in initial trials, SpaceOAR remains in early clinical use. Thus, we examined emerging safety reports as the system becomes more widely utilized. Methods: We reviewed the SpaceOAR manufacturer website for the safety profile and complications associated with the SpaceOAR hydrogel. We then compared this with reports submitted to the Manufacturer and User Facility Device Experience (MAUDE) database. Results: The manufacturer website reported risks including pain, needle penetration, and/or gel injection into a nearby organ or blood vessel, local inflammation, infection, urinary retention, and local rectal injury or symptoms. There were 22 unique reports discussing 25 patient cases in the MAUDE database from January 2015 to March 2019, with an increasing number of reports each year up through 2018. Unique major complications including acute pulmonary embolism, severe anaphylaxis, prostatic abscess and sepsis, purulent perineal drainage, rectal wall erosion, and rectourethral fistula were reported. Conclusion: Despite well-documented clinical benefits of the SpaceOAR System, there are a number of severe and debilitating complications recently reported in proximity to gel injection. This highlights the need for further study of device complications in light of its increasing clinical use.