BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 9860648 · Received March 20, 2020

    Report

    Report Number
    2135147-2020-00116
    Event Type
    Malfunction
    Date Received
    March 20, 2020
    Date of Event
    March 5, 2020
    Report Date
    April 8, 2020
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    UDI-DI
    00811806010076
    PMA / PMN Number
    P000039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OF DEFORMITY UPON DEPLOYMENT COULD NOT BE CONFIRMED. THE INVESTIGATION CONFIRMED THE DEVICE MET FUNCTIONAL SPECIFICATIONS WHEN ANALYZED AT ABBOTT UNDER NON-PHYSIOLOGICAL CONDITIONS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE CAUSE OF THE REPORTED EVENT REMAINS UNKNOWN.

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION REGARDING THIS EVENT HAS BEEN REQUESTED. INVESTIGATION RESULTS WILL BE PROVIDED IN A SUBSEQUENT SUBMISSION WHEN RECEIVED.

    Description of Event or Problem · 1

    A 10MM AMPLATZER SEPTAL OCCLUDER (9-ASD-010 LOT #7053280) WAS CHOSEN FOR ASD CLOSURE PROCEDURE. UPON DEPLOYING THE DEVICE THE LEFT ATRIAL DISK WAS "COBRA" MISALIGNED. THE USER TRIED SEVERAL DIFFERENT TECHNIQUES TO GET THE DEVICE TO DEPLOY BUT HE WAS UNSUCCESSFUL. HE PULLED A SECOND 10MM AMPLATZER SEPTAL OCCLUDER (9-ASD-010 LOT #7097787) AND THE DEVICE CLOSED THE DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322374 AMPLATZER SEPTAL OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV AGA MEDICAL CORPORATION 9-ASD-010 7053280 00811806010076

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Required Intervention