BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER AMULET

    MDR report key: 24666277 · Received March 23, 2026

    Report

    Report Number
    2135147-2026-01817
    Event Type
    Injury
    Date Received
    March 23, 2026
    Date of Event
    February 26, 2026
    Report Date
    May 19, 2026
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NGV
    UDI-DI
    00811806013480
    PMA / PMN Number
    P200049
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE REMAINS IMPLANTED IN PATIENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2026, A 25MM AMPLATZER AMULET WAS INITIALLY CHOSEN ALONG WITH 14F AMPLATZER TORQVUE DELIVERY SYSTEM. ACCORDING TO THE CASE SUPPORT REPRESENTATIVE, THE TRANSSEPTAL PUNCTURE WAS POSITIONED INFERIOR AND POSTERIOR (NOT INTENTIONALLY POSTERIOR), WHICH RESULTED IN A CHALLENGING TRAJECTORY TO THE LEFT ATRIAL APPENDAGE AND DIFFICULTY ACHIEVING PROPER DEVICE ORIENTATION. ACTIVATED CLOTTING TIME DURING THE PROCEDURE RANGED FROM 253¿340 SECONDS, AND HEPARIN WAS ADMINISTERED, WITH 20MG OF PROTAMINE GIVEN FOR REVERSAL. LEFT ATRIAL PRESSURE AT THE TIME OF THE PROCEDURE WAS REPORTED TO BE >12MMHG, AND THE PATIENT WAS IN NORMAL SINUS RHYTHM. THE WIRE WAS MAINTAINED IN THE LEFT UPPER PULMONARY VEIN FOR SAFETY, AND NO WIRE WAS PLACED DIRECTLY INTO THE LEFT ATRIAL APPENDAGE. THE 25MM DEVICE REQUIRED THREE RECAPTURES AND WAS ULTIMATELY FULLY WITHDRAWN FROM THE PATIENT DUE TO PERSISTENT ORIENTATION CHALLENGES. THE PROCEDURAL TEAM THEN PROCEEDED WITH A 22MM AMPLATZER AMULET DEVICE, THOUGH SIMILAR ORIENTATION DIFFICULTIES WERE ENCOUNTERED USING THE INITIAL SHEATH. AS A RESULT, A 14F AMULET STEERABLE SHEATH WAS INTRODUCED, AFTER WHICH THE 22MM DEVICE WAS SUCCESSFULLY IMPLANTED. A TOTAL OF TWO DELIVERY SHEATH EXCHANGES WERE PERFORMED DURING THE PROCEDURE. IT WAS NOTED THAT NO PERICARDIAL EFFUSION WAS PRESENT PRIOR TO THE PROCEDURE. THE PATIENT WAS RECEIVING ORAL ANTICOAGULANT THERAPY WITH PLAVIX AND XARELTO BOTH PRIOR TO AND AT THE TIME THE EFFUSION WAS DETECTED. ON (B)(6) 2026, DURING POST-PROCEDURE FOLLOW-UP, THE PATIENT DEVELOPED CHEST PAIN AND A CIRCUMFERENTIAL PERICARDIAL EFFUSION MEASURING UP TO 2.1CM, WITH CARDIAC TAMPONADE CONFIRMED BY ECHOCARDIOGRAPHY. THE PATIENT INITIALLY PRESENTED TO THE EMERGENCY DEPARTMENT ON (B)(6) 2026 AND WAS MONITORED FOLLOWING THIS VISIT. IT WAS LATER REPORTED THAT THE PATIENT UNDERWENT PERICARDIOCENTESIS ON (B)(6) 2026, WHICH RESOLVED THE EFFUSION. THE USER INDICATED A BELIEF THAT THE PERICARDIAL EFFUSION WAS RELATED TO MANIPULATION OF THE 25MM AMULET DEVICE OR POTENTIAL INTERACTION OF THE 22MM DEVICE DISC, WHICH MAY HAVE BEEN ORIENTED PERPENDICULAR TO THE LEFT UPPER PULMONARY VEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354022 AMPLATZER AMULET CARDIAC PLUG NGV ABBOTT MEDICAL 9-ACP2-007-022 10912037 00811806013480

    Patients

    Seq Age Sex Outcome Treatment
    1