BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER AMULET

    MDR report key: 20340085 · Received September 30, 2024

    Report

    Report Number
    2135147-2024-04805
    Event Type
    Injury
    Date Received
    September 30, 2024
    Date of Event
    May 20, 2024
    Report Date
    November 13, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NGV
    PMA / PMN Number
    P200049
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT OF NO APPARENT ADVERSE EVENT AND IMPROPER OR INCORRECT PROCEDURE OR METHOD WAS REPORTED. A RETURNED DEVICE ASSESSMENT COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE REPORTED IMPROPER OR INCORRECT PROCEDURE OR METHOD APPEARS TO BE RELATED TO USER DID NOT REPLACED THE DELIVERY SYSTEM. THE REPORTED NO APPARENT ADVERSE EVENT AS THERE WAS NOT ADVERSE EVENT TO THE PATIENT. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH REGARDS TO MANUFACTURE, DESIGN, OR LABELING. H6 - ADVERSE EVENT PROBLEM HEALTH EFFECT - CLINICAL CODE: 3271 REMOVED, 4582 ADDED. H6 - ADVERSE EVENT PROBLEM HEALTH EFFECT - IMPACT CODE: 4614 REMOVED, 2199 ADDED. H6 - ADVERSE EVENT PROBLEM HEALTH EFFECT - MEDICAL DEVICE PROBLEM CODE: 2017, 2993 REMOVED, 3189 ADDED.

    Additional Manufacturer Narrative · 0

    ¿ 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 (B)(6). IT WAS REPORTED THAT ON (B)(6) 2024, AN 25MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE (LAA) OCCLUDER (LOT: 9140510) WAS CHOSEN FOR IMPLANTATION UTILIZING A 12F AMPLATZER TORQVUE DELIVERY SYSTEM. DUE TO INCOMPATABILITY WITH THE ANATOMY, THE 25MM OCCLUDER WAS REMOVED. A REPLACEMENT 22MM AMULET LAA OCCLUDER (LOT: 9091966 )WAS THEN ATTEMPTED TO BE IMPLANTED, BUT WAS ALSO REMOVED DUE TO INCOMPATABILITY WITH THE ANATOMY. A THIRD 22MM AMULET LAA OCCLUDER (LOT: 9124399) WAS IMPLANTED SUCCESSFULLY. THE SAME DELIVERY SYSTEM WAS USED FOR ALL THREE DEVICES. THERE WERE NO PATIENT CONSEQUENCES OR CLINICALLY SIGNIFICANT DELAY. NO PERICARDIAL EFFUSION WAS OBSERVED.

    Description of Event or Problem · 0

    (B)(4). IT WAS REPORTED THAT ON (B)(6) 2024, AN 25MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE (LAA) OCCLUDER (LOT: 9140510) WAS CHOSEN FOR IMPLANTATION UTILIZING A 12F AMPLATZER TORQVUE DELIVERY SYSTEM. DUE TO INCOMPATIBILITY WITH THE ANATOMY, THE 25MM OCCLUDER WAS REMOVED. A REPLACEMENT 22MM AMULET LAA OCCLUDER (LOT: 9091966 ) WAS THEN ATTEMPTED TO BE IMPLANTED, BUT WAS ALSO REMOVED DUE TO INCOMPATIBILITY WITH THE ANATOMY. A THIRD 22MM AMULET LAA OCCLUDER (LOT: 9124399) WAS IMPLANTED SUCCESSFULLY. THE SAME DELIVERY SYSTEM WAS USED FOR ALL THREE DEVICES. POST PROCEDURE THE SAME DAY, TRACE PERICARDIAL EFFUSION WAS OBSERVED. PATIENT WAS ASYMPTOMATIC. UNSPECIFIED TREATMENT WAS PERFORMED. THE EFFUSION RESOLVED ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2006573 AMPLATZER AMULET CARDIAC PLUG NGV ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female Other