BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER AMULET

    MDR report key: 20417628 · Received October 10, 2024

    Report

    Report Number
    2135147-2024-04971
    Event Type
    Injury
    Date Received
    October 10, 2024
    Date of Event
    June 12, 2024
    Report Date
    December 31, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NGV
    UDI-DI
    00811806013497
    PMA / PMN Number
    P200049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A CIRCUMFERENTIAL PERICARDIAL EFFUSION DURING IMPLANT WAS REPORTED. THERE ARE MULTIPLE RISK FACTORS FOR PERICARDIAL EFFUSION AFTER A LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE, INCLUDING ANTICOAGULATION STATUS OF THE PATIENT, MANEUVERING OF THE GUIDEWIRE OR SHEATHS WITHIN THE HEART, THE TRANS-SEPTAL PUNCTURE, OR THE STABILIZING WIRES ON THE AMULET PUNCTURING THE LAA. IT WAS INDICATED THAT DURING THE PROCEDURE PATIENT'S ACTIVATED CLOTTING TIME (ACT) LEVEL WAS 249 SECONDS. IT WAS ALSO INDICATED THAT THE PERICARDIAL EFFUSION WAS RELATED TO PATIENT'S HEART FAILURE. NO CARDIAC TAMPONADE WAS OBSERVED. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND THE PRODUCT MET ALL SPECIFICATIONS. THE REPORTED INTERVENTION WAS A RESULT OF CASE-SPECIFIC CIRCUMSTANCES AS A MEDICATION WAS PROVIDED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO LABELING DESIGN OR MANUFACTURING OF THE DEVICE.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    CLINICAL INFORMATION: CRD_1056 - ADVANCE LAA, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2024, A 22MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE (LAA) OCCLUDER (LOT: 8673120) WAS CHOSEN FOR IMPLANTATION UTILIZING A 14F AMPLATZER TORQVUE DELIVERY SYSTEM (LOT: 9120197). THE PATIENT PRESENTED IN SINUS RHYTHM. THE 22MM OCCLUDER WAS REMOVED DUE TO INCOMPATIBILITY WITH ANATOMY. A REPLACEMENT 25MM AMULET OCCLUDER (LOT: 9207580) WAS IMPLANTED SUCCESSFULLY UTILIZING THE SAME DELIVERY SYSTEM. LEFT ATRIAL PRESSURE WAS 16MMHG, NO FLUIDS WERE ADMINISTERED. MINIMUM ACTIVATED CLOTTING TIME WAS 249 SECONDS. 36 HOURS POST PROCEDURE, A 5.63MM-8.60MM SMALL/TRIVIAL CIRCUMFERENTIAL PERICARDIAL EFFUSION WAS OBSERVED POSTERIOR TO THE HEART IN TRANSVERSE SINUS. THERE WAS NO EVIDENCE OF HEMODYNAMIC COMPROMISE. NO INTERVENTION WAS PERFORMED. IT WAS THOUGHT THE PERICARDIAL EFFUSION WAS RELATED TO PATIENT'S HEART FAILURE/PERICARDITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2345482 AMPLATZER AMULET CARDIAC PLUG NGV ABBOTT MEDICAL 9207580 00811806013497

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Required Intervention