BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER AMULET

    MDR report key: 22828298 · Received August 18, 2025

    Report

    Report Number
    2135147-2025-04594
    Event Type
    Injury
    Date Received
    August 18, 2025
    Date of Event
    July 24, 2025
    Report Date
    September 18, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NGV
    UDI-DI
    00811806013497
    PMA / PMN Number
    P200049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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.

    Additional Manufacturer Narrative · 0

    AN EVENT OF PERICARDIAL EFFUSION AND IMPROPER OR INCORRECT METHOD WAS REPORTED. IT WAS INDICATED THAT THE ACT LEVEL WAS 250-350 SECONDS. THERE WERE MORE THAN 4 PARTIAL RECAPTURES OF THE OCCLUDER. A RETURNED DEVICE ASSESSMENT COULD NOT BE PERFORMED AS THE DEVICE REMAINS IMPLANTED AND WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED, AND THE PRODUCT MET ALL SPECIFICATIONS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. IT IS POSSIBLE PROCEDURAL CONDITION CONTRIBUTED THE REPORTED EVENT; HOWEVER, THIS CANNOT BE CONFIRMED. THE REPORTED UNEXPECTED MEDICAL INTERVENTION WAS A RESULT OF CASE-SPECIFIC CIRCUMSTANCES AS PERICARDIOCENTESIS WAS PERFORMED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO LABELING DESIGN OR MANUFACTURING OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6)2025, A 25MM AMPLATZER LEFT ATRIAL APPENDAGE (LAA) OCCLUDER WAS CHOSEN FOR IMPLANTATION UTILIZING A 12F AMPLATZER TORQVUE 45X45 DELIVERY SYSTEM CONCOMITANT TO A PVI/AF ABLATION WITH A NON-ABBOTT DEVICE. ACTIVATED CLOTTING TIME (ACT) WAS 250-350 SECONDS. 12,000 UNITS OF HEPARIN WAS ADMINISTERED. LEFT ATRIAL PRESSURE WAS GREATER THAN 12MMHG. PATIENT WAS IN SINUS RHYTHM. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE AND DEVICE WAS IMPLANTED SUCCESSFULLY AFTER 4 PARTIAL RECAPTURES. PROTAMINE ADMINISTERED. SIX HOURS POST PROCEDURE, IT WAS LEARNED THAT THE PATIENT DEVELOPED A CIRCUMFERENTIAL PERICARDIAL EFFUSION. PERICARDIOCENTESIS WAS PERFORMED WHICH DRAINED 450 ML OF FLUID. THE IS STABLE AND A CHEST TUBE REMAINS. THE CAUSE OF THE EFFUSION IS UNKNOWN. PATIENT WAS TAKING ORAL ANTICOAGULANTS BEFORE AND AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1761947 AMPLATZER AMULET CARDIAC PLUG NGV ABBOTT MEDICAL 9-ACP2-010-025 10551543 00811806013497

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Hospitalization| R