BEUDAMED
    FDA Adverse Event Death Summary report: N

    AVEIR LEADLESS RV PACER -- LEADLESS PACEMAKER

    MDR report key: 24068163 · Received January 14, 2026

    Report

    Report Number
    MW5182224
    Event Type
    Death
    Date Received
    January 14, 2026
    Date of Event
    May 9, 2025
    Report Date
    October 9, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PNJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PATIENT UNDERWENT ATTEMPTED LEADLESS DUAL-CHAMBER PACEMAKER (ABBOTT MEDICAL AVEIR -- LEADLESS RV PACER) IMPLANTATION ON (B)(6) 2025 AT (B)(6) HOSPITAL. PATIENT WAS 11 DAYS POST MVR (MITRAL VALVE REGURGITATION)/TVR (TRICUSPID VALVE REGURGITATION)/MAZE/CABG (CORONARY ARTERY BYPASS GRAFT) AND ON THERAPEUTIC ANTICOAGULATION. ACCORDING TO THE HOSPITAL'S RECORDS AND SUBSEQUENT COMMUNICATIONS, THE DEVICE WAS DEPLOYED AND RECAPTURED TWICE. DURING CATHETER MANIPULATION/TESTING, AN IATROGENIC INTRA-PROCEDURAL CARDIAC PERFORATION OCCURRED, FOLLOWED BY RAPID CLINICAL DETERIORATION AND DEATH DESPITE RESUSCITATIVE EFFORTS. HOSPITAL STATES AN MDR/MAUDE WAS FILED BUT, TO MY KNOWLEDGE, HAS NOT BEEN AMENDED TO INCLUDE COMPLETE INFORMATION. THE REPORT LISTED THE CAUSE OF DEATH AS "HYPOTENSION", HOWEVER, THE DEATH CERTIFICATE IDENTIFIES THE CAUSE AS "RIGHT VENTRICULAR PERFORATION". THE HOSPITAL STATES IT SEES NO NEED TO AMEND IT. I AM SUBMITTING THIS REPORT BECAUSE THE CURRENT PUBLIC MAUDE ENTRY APPEARS INCOMPLETE/INACCURATE (EVENT NARRATIVE AND OUTCOME) AND TO REQUEST THAT FDA AND THE MANUFACTURER OBTAIN AND FILE A SUPPLEMENTAL MDR REFLECTING THE FULL FACTS. I WILL PROVIDE ADDITIONAL RECORDS (EP (ELECTROPHYSIOLOGY) REPORT, CATH/ICU DOCUMENTATION, DEATH CERTIFICATE, ETC.) AS NEEDED. MDR REPORT KEY: (B)(4), MDR TEXT KEY: (B)(4); REPORT NUMBER: MW5170595. REFERENCE REPORT: MW5177178. PATIENT CODES: 4559, 4868, 1841, 1914. DEVICE CODE: 2993.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127463 AVEIR LEADLESS RV PACER -- LEADLESS PACEMAKER LEADLESS PACEMAKER PNJ ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Death