MP-453087-5 ADVERSE EVENTS ASSOCIATED WITH AVEIRTMVR LEADLESS PACEMAKER: A FOOD AND DRUG ADMINISTRATION MAUDE DATABASE STUDY

Abstract

Since the first pacemaker implantation, much of the effort has been focused on battery longevity and device miniaturization. Leadless pacemaker offers an innovative approach to the treatment of bradyarrhythmias, thus avoiding long-term lead-related complications. Recently, the Aveir (screw-in type leadless pacemaker) (Abbott) has been approved by the Food and Drug Administration (FDA). We queried the FDA Manufacturer And User Facility Device Experience (MAUDE) database to study the safety profile and assess the types of complications with this relatively novel device technology. The MAUDE database is a repository of industry and patient/physician-reported medical device adverse events. A MAUDE database search was conducted on November 10, 2022, for reports received post-FDA approval to capture all adverse events. A total of 42 events (after removing duplicate entries or programmer or introducer sheath-related issues n=13) were reported for Aveir leadless pacemaker post-FDA approval. The most frequently reported issue was a device malfunction-related event (n=36, 85.7%). The most commonly encountered problem was the capture issue (28.6%, 12 events), followed by the sensing issue (19%, 8 events), high impedance (19%, 8 events), stretched helix (19%, 8 events), device dislodgement (14.3%, 6 events), device separation failure (14.3%, 6 events), premature separation (4.8%, 2 events), material twist (4.8%, 2 events), and broken helix (2.4%, 1 event). As such, this resulted in pericardial effusion requiring pericardiocentesis (9.5%, 4 events), cardiac perforation (9.5%, 4 events), and arrhythmia (2.4%, 1 event). This resulted in one death. Aveir leadless pacemaker implantation may be complicated by myocardial perforations and tears that result in cardiac tamponade and death. Our study is limited by heterogeneity in reporting, and lack of assessment of the total number of cases performed per year; thus, warranting better transparency and monitoring mechanisms.