Adverse events associated with AveirTM VR leadless pacemaker: A Food and Drug Administration MAUDE database study

Abstract

AbstractBackgroundLeadless pacemaker (LP) offers an innovative approach for treating bradyarrhythmia, thus avoiding pacemaker pocket and lead‐related complications. The Food and Drug Administration (FDA) has recently approved the Aveir™ leadless pacing system (screw‐in type LP).MethodsWe queried the FDA MAUDE database to study the safety profile and assess the types of complications with this relatively novel device technology. A MAUDE database search was conducted on January 20, 2023, for reports received post‐FDA approval to capture all adverse events.ResultsA total of 98 medical device report were reported for Aveir™ LP. After excluding duplicate, programmer‐related, or introducer‐sheath‐related entries (n = 34), 64 entries were included. The most commonly encountered problem was high threshold/noncapture (28.1%, 18 events), followed by stretched helix (17.2%, 11 events) and device dislodgement (15.6%, ten events—5 intraprocedural, while 5 in the postoperative Day 1). Other reported events included high impedance (14.1%, nine events), sensing issues (12.5%, eight events), bent/broken helix (7.8%, five events), premature separation (4.7%, three events), interrogation problem (3.1%, two events), low impedance (3.1%, two events), premature battery depletion (1.6%, one event) and inadvertent MRI mode switch (1.6%, one event) and miscellaneous (15.6%, n = 10). There were eight serious patient injury events—pericardial effusion requiring pericardiocentesis (7.8%, five events) due to cardiac perforation that resulted in two deaths (3.1%) followed by sustained ventricular arrhythmias (4.6%, n = 3).ConclusionIn our study assessing the real‐world safety profile of the Aveir™ LP, serious adverse events have been reported—life‐threatening ventricular arrhythmias, pericardial effusion, device explantation/reimplantation, and death.