BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZER AMULET

    MDR report key: 20385087 · Received October 7, 2024

    Report

    Report Number
    2135147-2024-04915
    Event Type
    Malfunction
    Date Received
    October 7, 2024
    Date of Event
    April 24, 2024
    Report Date
    November 19, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NGV
    UDI-DI
    00811806013480
    PMA / PMN Number
    P200049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT DURING A FOLLOW-UP A 3 THERE WAS A 5 MM RESIDUAL SHUNT OBSERVED AROUND THE OCCLUDER. THE PATIENT WAS NOT EXPERIENCING ANY SYMPTOMS. ALSO REPORTED THAT DUE TO INCOMPATIBILITY WITH ANATOMY (MIS-SIZING), THE 18 MM AMULET OCCLUDER WAS REMOVED AND REPLACED WITH A 22 MM AMULET OCCLUDER UTILIZING THE SAME DELIVERY SYSTEM. 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.¿ BASED ON CINE REVIEW PERFORMED AT ABBOTT, A LEAK WAS PRESENT AT IMPLANT. NO VIEW OF THE RELEASED DEVICE IN THE 0-DEGREE VIEW WITH COLOR WAS PRESENT ON THE DAY OF PROCEDURE TO COMPARE LEAK SIZE. A LEAK WAS PRESENT IN THE 0-DEGREE VIEW WITH THE DEVICE STILL ATTACHED TO THE DELIVERY CABLE MEASURING 4-6 MM. THE REVIEW CONFIRMS THE REPORTED EVENT OF LEAK THAT WAS STILL PRESENT IN THE 0-DEGREE ANGLE MEASURING 3.4 MM TO 5.85 MM AFTER 3 MONTHS OF DEVICE IMPLANT. BASED ON THE CINE REVIEW, THE LEAK EXISTED AT THE TIME OF DEVICE IMPLANT; HOWEVER, THE EXACT CAUSE OF THE LEAK COULD NOT BE CONCLUSIVELY DETERMINED. THE DEVICE REMAINS IMPLANTED AND WILL NOT BE RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND THE PRODUCT MET SPECIFICATIONS. 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.

    Description of Event or Problem · 0

    CRD_1056 SITE PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2024, A 18MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE (LAA) OCCLUDER (LOT: 8871642) WAS CHOSEN FOR IMPLANTATION UTILIZING A 14F AMPLATZER TORQVUE DELIVERY SYSTEM (LOT: 8183056). DUE TO INCOMPATIBILITY WITH ANATOMY (MIS-SIZING), THE 18MM OCCLUDER WAS REMOVED AND REPLACED WITH A 22MM AMULET OCCLUDER (LOT: 8921120). UTILIZING THE SAME DELIVERY SYSTEM, THE OCCLUDER WAS IMPLANTED SUCCESSFULLY AFTER ONE PARTIAL RECAPTURE. ON (B)(6) 2024, DURING A FOLLOW-UP A 3,5MM RESIDUAL SHUNT WAS OBSERVED AROUND THE OCCLUDER. THE PATIENT WAS NOT EXPERIENCING ANY SYMPTOMS. NO INTERVENTION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283444 AMPLATZER AMULET CARDIAC PLUG NGV ABBOTT MEDICAL 8921120 00811806013480

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Other