BEUDAMED
    FDA Adverse Event Death Summary report: N

    AVEIR¿ LEADLESS PACEMAKER, RIGHT VENTRICLE

    MDR report key: 19001310 · Received March 28, 2024

    Report

    Report Number
    2017865-2024-37174
    Event Type
    Death
    Date Received
    March 28, 2024
    Report Date
    March 28, 2024
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    PNJ
    PMA / PMN Number
    P150035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION E: WILEY TITLE: A COMPARATIVE STUDY OF THE TWO LEADLESS PACEMAKERS IN CLINICAL PRACTICE. (J CARDIOVASC ELECTROPHYSIOL. 2023;34:1896-1903. DOI:10.1111/JCE.16019 ) AUTHORS: GHANSHYAM SHANTHA MD, MPH; JONATHAN BROCK MD; MATTHEW J. SINGLETON MD, MBE, MHS, MSC; ALEXANDER JOSEPH SCHMITT MD; PATRICK KOZAK MD; GEORGE BODZIOCK MD; NATALIE BRADFORD MD; PATRICK WHALEN MD; PRASHANT BHAVE MD.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE NUMBER: (B)(4). IT WAS REPORTED AVEIR LEADLESS PACEMAKERS (LP) WERE USED AS PART OF A STUDY INVOLVING AVEIR AND MICRA LEADLESS PACEMAKERS. THIS EVENT IT TO REPORT THE OBSERVATIONS ON THE AVEIR LPS USED IN THE STUDY. THE STUDY REVIEWED TWENTY-FIVE CONSECUTIVE PATIENTS WHO RECEIVED AVEIR LPS BETWEEN MAY AND NOVEMBER 2022 FROM IMPLANT TO TEN WEEKS POST-IMPLANT. DURING ONE IMPLANT ATTEMPT, THE AVEIR LP HAD DIFFICULTY RELEASING FROM THE DELIVERY CATHETER WHICH RESULTED IN DISLODGEMENT AND INCREASED CAPTURE THRESHOLDS. THE AVEIR LP WAS SUCCESSFULLY RETRIEVED AND REPOSITIONED. THE STUDY DISCUSSED THE SAFETY OF AVEIR LPS, REFERENCING THE AVEIR VR TRIALS. THE REFERENCE CITED PERICARDIAL EFFUSION AND CARDIAC TAMPONADE WERE THE COMMONEST COMPLICATIONS WITH AN INCIDENCE BETWEEN 0.3% AND 1%. SOME OF THESE PATIENTS NEEDED STERNOTOMY AND 1 PATIENT DIED IN THESE TRIALS. VASCULAR ACCESS COMPLICATIONS, PERICARDITIS, STROKE, PULMONARY EMBOLISM, AND CONTRAST NEPHROPATHY HAVE BEEN REPORTED WITH INCIDENCE <0.3% AND DEVICE DISLODGEMENT WITH REIMPLANTATION HAPPENED IN 1.5% OF IMPLANTS IN THESE TRIALS. THE STUDY STATED, OF THESE COMPLICATIONS, ONLY THE ONE CASE OF DISLODGEMENT OCCURRED WITHIN THE TWENTY-FIVE IMPLANTS OF THE STUDY BUT WAS HESITANT TO DRAW ANY INFERENCES ON SAFETY DUE TO THE DIFFERENCE IN SAMPLE SIZE AND SHORT TERM FOLLOW-UP LIMITS. THE STUDY CONCLUDED THAT AVEIR LPS WERE SIMILAR IN EFFECTIVENESS AND SAFETY COMPARED TO MICRA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2583433 AVEIR¿ LEADLESS PACEMAKER, RIGHT VENTRICLE Leadless pacemaker PNJ ST. JUDE MEDICAL, INC.(CRM-SYLMAR) LSP112V

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death