BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER AMULET

    MDR report key: 16117188 · Received January 6, 2023

    Report

    Report Number
    2135147-2023-00087
    Event Type
    Injury
    Date Received
    January 6, 2023
    Date of Event
    December 12, 2022
    Report Date
    February 25, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NGV
    UDI-DI
    00811806013480
    PMA / PMN Number
    P200049
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    NAD1 - BRAND NAME: CORRECTED TO AMPLATZER AMULET. D2A - COMMON DEVICE NAME: CORRECTED TO CARDIAC PLUG. D2B - PROCODE: CORRECTED TO NGV. D4 - LOT #: CORRECTED TO 8616771. D4 - CATALOG #: CORRECTED TO 9-ACP2-007-022. D4 - EXPIRATION DATE: CORRECTED TO 7/31/2027. D4 - UDI #: CORRECTED TO (B)(4). D6A - IMPLANT DATE: (B)(6) 2022.

    Additional Manufacturer Narrative · 0

    AN EVENT OF PERICARDIAL EFFUSION AND CARDIAC TAMPONADE WAS REPORTED. 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.H6 DEVICE CODE 4001 PATIENT DEVICE INTERACTION PROBLEM REMOVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2022, A 22MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS CHOSEN FOR IMPLANT USING A 12FR AMPLATZER AMULET DELIVERY SHEATH. POST-PROCEDURE THE PATIENT HAD PERICARDIAL EFFUSION WHICH LED TO CARDIAC TAMPONADE. THE PATIENT UNDERWENT PERICARDIOCENTESIS AND WAS DRAINED SUCCESSFULLY ON THE SAME DAY AS THE PROCEDURE. THE PATIENT'S ACTIVATED CLOTTING TIME WAS 350 SECONDS. VENOUS BLOOD WAS PULLED AND THE PHYSICIAN BELIEVES THE EFFUSION WAS CAUSED BY A TRANSVERSE SINUS INJURY. THE PATIENT IS CURRENTLY STABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2022, A 22MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS SUCCESSFULLY IMPLANTED USING A 12FR AMPLATZER TORQVUE 45X45 DELIVERY SHEATH. DURING THE PROCEDURE, THE PATIENT'S ACTIVATED CLOTTING TIME WAS 350 SECONDS. HEPARIN WAS ADMINISTERED. THERE WAS NO DIFFICULTY IMPLANTING THE DEVICE DURING THE PROCEDURE. POST-PROCEDURE, THE PATIENT HAD PERICARDIAL EFFUSION WHICH LED TO CARDIAC TAMPONADE. THE PATIENT UNDERWENT PERICARDIOCENTESIS AND WAS SUCCESSFULLY DRAINED ON THE SAME DAY AS THE PROCEDURE. VENOUS BLOOD WAS PULLED, AND THE PHYSICIAN BELIEVES THE PERICARDIAL EFFUSION WAS POTENTIALLY CAUSED BY A TRANSVERSE SINUS INJURY. THE PATIENT WAS REPORTED AS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634375 AMPLATZER AMULET CARDIAC PLUG NGV ABBOTT MEDICAL 9-ACP2-007-022 8616771 00811806013480

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male Required Intervention| L