BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER AMULET

    MDR report key: 19407949 · Received May 28, 2024

    Report

    Report Number
    2135147-2024-02419
    Event Type
    Injury
    Date Received
    May 28, 2024
    Date of Event
    May 1, 2024
    Report Date
    July 26, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NGV
    UDI-DI
    00811806013497
    PMA / PMN Number
    P200049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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

    AN EVENT OF ST ELEVATION DUE TO AIR EMBOLISM DURING DEVICE IMPLANTATION WAS REPORTED. IT WAS REPORTED THAT THE ISSUE RESOLVED WITHOUT INTERVENTION AND WITHOUT PATIENT SEQUELAE. FIELD INDICATED THAT THERE WAS NO DEVICE MALFUNCTION NOTED THAT MAY HAVE CONTRIBUTED TO AIR EMBOLISM. NO AIR WAS OBSERVED IN PATIENT ANATOMY. INFORMATION FROM FIELD INDICATED THAT THREE OTHER AMULET DEVICES WERE ATTEMPTED TO BE IMPLANTED AS REPLACEMENT USING SAME DELIVERY SYSTEM FOR ALL DEVICES. PLEASE NOTE THAT PER THE INSTRUCTIONS FOR USE, "IF THE DEVICE IS RETRACTED WHILE IT IS IN THE SHEATH, THE DEVICE AND THE SHEATH MUST BOTH BE REMOVED AND REPLACED. FAILURE TO REPLACE BOTH THE DEVICE AND THE SHEATH MAY RESULT IN SHEATH AND/OR DEVICE MALFUNCTION." A RETURNED DEVICE INSPECTION, TO RULE OUT ANY DEVICE-RELATED CAUSES, 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. BASED ON THE INFORMATION RECEIVED, CAUSE OF AIR EMBOLISM COULD NOT BE CONCLUSIVELY DETERMINED. 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

    CRD_1056 - ADVANCE LAA PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2024, A AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER (LAAO) WAS CHOSEN FOR IMPLANTATION UTILIZING A 12F AMPLATZER STEERABLE DELIVERY SHEATH. PATIENT WAS UNDER GENERAL ANESTHESIA. A 25MM AMULET (LOT: 8991044) WAS CHOSEN FOR IMPLANTATION. DURING IMPLANTATION, TRANSIENT INFERIOR ST ELEVATION WAS OBSERVED LASTING LESS THAN 5 MINUTES. THE CAUSE WAS ASSUMED TO BE AN AIR EMBOLISM. NO WALL ABNORMALITY NOTED ON CORONARY ARTERY ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). NO ARRYTHMIA NOTED. THE ISSUE RESOLVED WITHOUT INTERVENTION AND WITHOUT PATIENT SEQUELAE. THE DEVICE WAS REMOVED. A REPLACEMENT 25MM AMULET (LOT: 9047919) WAS THEN ATTEMPTED TO BE IMPLANTED BUT WAS REMOVED DUE TO MIS-SIZING WITH NO DEVICE ISSUES. A REPLACEMENT A 22MM AMULET (LOT: 9049881) WAS ATTEMPTED TO BE IMPLANTED BUT WAS REMOVED DUE TO MIS-SIZING WITH NO DEVICE ISSUES. A FOURTH 22MM AMULET (LOT: 9066851) WAS THEN IMPLANTED SUCCESSFULLY. THE SAME DELIVERY SYSTEM WAS USED FOR ALL AMULETS. THERE WAS NO OBVIOUS DEVICE MALFUNCTION NOTED THAT MAY HAVE CONTRIBUTED TO AIR EMBOLISM. NO AIR WAS OBSERVED IN PATIENT ANATOMY. NO ASPIRATION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1214956 AMPLATZER AMULET CARDIAC PLUG NGV ABBOTT MEDICAL 9-ACP2-010-025 8991044 00811806013497

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Other DS-TV45X45-12F-080 LOT: 9154245