BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 14322029 · Received May 7, 2022

    Report

    Report Number
    2135147-2022-00251
    Event Type
    Malfunction
    Date Received
    May 7, 2022
    Date of Event
    April 11, 2022
    Report Date
    July 28, 2022
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MLV
    UDI-DI
    00811806010236
    PMA / PMN Number
    P000039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 COBRA SHAPE DEFORMATION WAS REPORTED. THREE IMAGES WERE RECEIVED FROM THE FIELD WHICH APPEARED TO SHOW AN OCCLUDER IN A COBRA DEFORMATION HOWEVER WHEN THE DEVICE WAS RETURNED TO ABBOTT FOR INVESTIGATION THE DEVICE MET FUNCTIONAL SPECIFICATIONS WHEN ANALYZED UNDER NON-PHYSIOLOGICAL CONDITIONS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND THE PRODUCT MET ALL DEFINED MANUFACTURING SPECIFICATIONS. THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 32MM AMPLATZER SEPTAL OCCLUDER AND A 18MM SEPTAL OCCLUDER WERE SELECTED FOR A DOUBLE ATRIAL SEPTAL DEFECT CLOSURE PROCEDURE ON (B)(6) 2022. AN 18MM AMPLATZER SEPTAL OCCLUDER WAS PLACED AND RELEASED SUCCESSFULLY. THEN AN ATTEMPT WAS MADE TO PLACE A 32 MM AMPLATZER SEPTAL OCCLUDER (LOT # 7170020). DURING THE ATTEMPT TO DEPLOY THE 32MM AMPLATZER ATRIAL SEPTAL OCCLUDER, THE DEVICE PRESENTED IN A COBRA SHAPE DEFORMATION. THE OCCLUDER WAS RE-SHEATHED AND REDEPLOYED ONE TIME WITH THE SAME ISSUE. THE DEVICE WAS RETRIEVED FROM THE PATIENT PRIOR TO RELEASE FROM THE DELIVERY SYSTEM AND EXCHANGED WITH A NEW, 30MM AMPLATZER SEPTAL OCCLUDER. BOTH THE 18MM AND THE 30MM AMPLATZER SEPTAL OCCLUDERS WERE PLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1295302 AMPLATZER SEPTAL OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV ABBOTT MEDICAL SEPTAL OCCLUDER 7170020 00811806010236

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male 12F AMPLATZER TREVISIO DS: 9-ATV12F45/80, 7035034