BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMPLATZER AMULET

    MDR report key: 18413940 · Received December 28, 2023

    Report

    Report Number
    2135147-2023-05777
    Event Type
    Death
    Date Received
    December 28, 2023
    Date of Event
    December 7, 2023
    Report Date
    January 22, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NGV
    UDI-DI
    00811806013503
    PMA / PMN Number
    P200049
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT OF DEVICE EMBOLIZATION IN TO THE AORTIC VALVE WAS REPORTED. IT WAS REPORTED THAT PATIENT DEVELOPED RESPIRATORY DISTRESS WHILE IN THE POST ACUTE CARE UNIT WHICH QUICKLY PROGRESSED TO CARDIOPULMONARY RESUSCITATION (CPR) AND REQUIRED ADVANCED CARDIAC LIFE SUPPORT. THE PATIENT WAS EMERGENTLY TAKEN TO THE OPERATING ROOM TO REMOVE THE EMBOLIZED DEVICE. THE PATIENT DEATH WAS REPORTED. THE PATIENT MEDICAL HISTORY INCLUDED ANEMIA, ATRIAL FIBRILLATION AND PCI. A RETURNED DEVICE ASSESSMENT COULD NOT BE PERFORMED AS THE DEVICE 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. IMAGES FROM FIELD APPEARED TO SHOW COLOR FLOW WITHOUT LEAKAGE IN 45/135 VIEW, NO LEAKAGE WAS SEEN AT THE LOBE. AT THE TIME OF DEVICE RELEASE, THE 0- AND 135-DEGREE TEE VIEWS SHOWED A DEVICE LOBE SHOULDER THAT WAS TOO PROXIMAL FOR CLOSE TO BE MET WHICH COULD POSSIBLY CAUSE DIFFICULTY OBTAINING THE COAXIALITY, COMPROMISING DEVICE DELIVERY. A POST PROCEDURE TTE IMAGE SERIES SHOWED THE AMULET DEVICE EMBOLIZED FROM THE LAA. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO LABELING DESIGN OR MANUFACTURING OF THE DEVICE.

    Additional Manufacturer Narrative · 0

    D4 - THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 0

    CRD_1056 - ADVANCE LAA US1799-486 R813470501. IT WAS REPORTED THAT ON 07 DEC. 2023, AN UNKNOWN AMPLATZER AMULET WAS IMPLANTED IN A PATIENT. PATIENT REPORTEDLY COUGH UPON EXTUBATION POST PROCEDURE. PATIENT DEVELOPED RESPIRATORY DISTRESS WHILE IN THE POST ACUTE CARE UNIT WHICH QUICKLY PROGRESSED TO CARDIOPULMONARY RESUSCITATION (CPR) AND ADVANCED CARDIAC LIFE SUPPORT, ADVANCED CARDIOVASCULAR LIFE SUPPORT (ACLS) PROTOCOL. AN EMERGENT ECHOCARDIOGRAM ORIGINALLY NOTED THE AMULET DEVICE IN THE MITRAL VALVE AND SUBSEQUENTLY MIGRATED TO THE AORTIC VALVE. AFTER RETURN OF SPONTANEOUS CIRCULATION (ROSC), THE PATIENT WAS EMERGENTLY TAKEN TO THE OPERATING ROOM TO REMOVE THE DEVICE. IT'S NOTED THAT THE PATIENT PASSED AWAY ON (B)(6) 2023. THE CAUSE OF DEATH IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1400930 AMPLATZER AMULET CARDIAC PLUG NGV ABBOTT MEDICAL 8835805 00811806013503

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Death