Adverse Events With Intravascular Lithotripsy After Peripheral and Off-Label Coronary Use: A Report From the FDA MAUDE Database

Yashasvi Chugh, Jaikirshan J. Khatri, Mehdi H. Shishehbor, Subhash Banerjee, Kevin Croce, Khaldoon Alaswad, Bilal Murad, Santiago Garcia, M. Nicholas Burke, Emmanouil S. Brilakis

Research output: Contribution to journalArticlepeer-review

Abstract

BACKGROUND: Currently only the peripheral intravascular lithotripsy (IVL) device is approved for use in the United States. We queried the United States Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database from January 1, 2016 to December 14, 2020 for all reports of adverse events and modes of failure related to the peripheral IVL device, when used for on- and off-label indications. There were 20 reports of use in peripheral artery disease interventions and 3 reports of off-label use in coronary interventions. Device malfunction in 13 of 23 patients (56.5%) was the most common adverse event reported. Partial balloon or catheter dislodgment was the most common mode of IVL device failure in 12 of 20 patients (60%), followed by balloon rupture in 3 of 20 patients (15%). Coronary use was rare, and associated with balloon perforation in 1 of 3 patients, bradycardia in 1 of 3 patients, and aortocoronary dissection in 1 of 3 patients. In summary, IVL use carries risk of complications; hence, continued vigilance and postmarketing monitoring are warranted.

Original languageEnglish (US)
Pages (from-to)E974-E977
JournalThe Journal of invasive cardiology
Volume33
Issue number12
StatePublished - Dec 1 2021

Keywords

  • intravascular lithotripsy
  • peripheral artery disease

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

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