Adverse events with intravascular lithotripsy after coronary use: A report from the FDA MAUDE database.

ABSTRACT

Percutaneous coronary intervention (PCI) on heavily calcified lesions has been associated with more complications.1 Intravascular lithotripsy (IVL) was recently approved for treating de novo calcified coronary lesions based on excellent safety and efficacy on several studies, but there are limited "real world" outcomes. We conducted a comprehensive search of the MAUDE database between February 12, 2021, and February 28, 2023 using the manufacturer and brand name tabs with the keywords "Shockwave Medical" and "Shockwave," respectively. Given that a single IVL catheter can fail or cause multiple adverse events through different mechanisms, we considered all possible outcomes. The MAUDE database is freely accessible and de-identified, obviating the need for institutional review board approval.