BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 11898297 · Received May 27, 2021

    Report

    Report Number
    2135147-2021-00204
    Event Type
    Malfunction
    Date Received
    May 27, 2021
    Date of Event
    May 20, 2021
    Report Date
    June 14, 2021
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MLV
    UDI-DI
    00811806010052
    PMA / PMN Number
    P000039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OF DEVICE DEFORMITY COULD NOT BE CONFIRMED. THE INVESTIGATION CONFIRMED THE DEVICE MET VISUAL AND 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 AND THE PRODUCT MET ALL SPECIFICATIONS. THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2021 A 8MM AMPLATZER SEPTAL OCCLUDER (LOT# 6533560 ) WAS CHOSEN FOR PROCEDURE. DURING THE PROCEDURE, DURING THE DEPLOYMENT OF THE DEVICE, THE LEFT ATRIAL DISK PRESENTED WITH A DEFORMATION, A "COBRA" SHAPE. THE DEVICE WAS REMOVED FROM THE PATIENT AND EXCHANGED WITH A NEW 8 MM AMPLATZER SEPTAL OCCLUDER (LOT #7800708). NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION PROVIDED (B)(6) 2021, PM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788517 AMPLATZER SEPTAL OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV ABBOTT MEDICAL 9-ASD-008 6533560 00811806010052

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR