BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER AMULET

    MDR report key: 17848333 · Received September 29, 2023

    Report

    Report Number
    2135147-2023-04258
    Event Type
    Injury
    Date Received
    September 29, 2023
    Date of Event
    September 7, 2023
    Report Date
    November 9, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NGV
    UDI-DI
    00811806013503
    PMA / PMN Number
    P200049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT RETURNING 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 LOW BLOOD PRESSURE/HYPOTENSION AND PERICARDIAL EFFUSION LEAD TO CARDIAC TAMPONADE WAS REPORTED. 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. REPORTEDLY, DURING PROCEDURE, THE PHYSICIAN WAS LOOKING FOR THE RIGHT POSITIONING OF THE DEVICE INSIDE THE LAA, SOME CARDIAC EFFUSION WAS NOTED. THE AMULET WAS IMPLANTED AFTER MULTIPLE MANIPULATIONS AND THERE WAS A DIFFICULTY TO TRYING TO GET THE RIGHT DEVICE ALIGNMENT WITH RESPECT TO THE LAA AXES. DUE TO PERICARDIAL EFFUSION, CARDIAC TAMPONADE WAS NOTED AND PERICARDIOCENTESIS WAS PERFORMED. THE PHYSICIAN MENTIONED PATIENT HAD HYPOTENSION IN CATHETER LAB. THE PATIENT WAS MOVED TO THE SURGICAL ROOM TO SOLVE TAMPONADE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH REGARDS TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2023, A 28MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS CHOSEN FOR A LEFT ATRIAL APPENDAGE (LAA) CLOSURE USING A 14F AMPLATZER AMULET DELIVERY SHEATH. DURING PROCEDURE, HEPARIN WAS ADMINISTERED AND THE PHYSICIAN WAS LOOKING FOR THE RIGHT POSITIONING OF THE DEVICE INSIDE THE LAA, SOME CARDIAC EFFUSION WAS NOTED. THE AMULET WAS IMPLANTED AFTER MULTIPLE MANIPULATIONS AND THERE WAS A DIFFICULTY TO TRYING TO GET THE RIGHT DEVICE ALIGNMENT WITH RESPECT TO THE LAA AXES. THERE THE DEVICE WAS IN THE PERICARDIUM. A PERICARDIOCENTESIS WAS PERFORMED. DUE TO PERICARDIAL EFFUSION CARDIAC TAMPONADE WAS NOTED. THE PHYSICIAN MENTIONED PATIENT HAD HYPOTENSION IN CATHETER LAB. THE PATIENT WAS MOVED TO THE SURGICAL ROOM TO SOLVE TAMPONADE. THE PATIENT WAS REPORTED STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2278856 AMPLATZER AMULET CARDIAC PLUG NGV ABBOTT MEDICAL 8599244 00811806013503

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| R| H