BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 10355847 · Received August 3, 2020

    Report

    Report Number
    2135147-2020-00352
    Event Type
    Malfunction
    Date Received
    August 3, 2020
    Date of Event
    July 8, 2020
    Report Date
    August 24, 2020
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    UDI-DI
    00811806010090
    PMA / PMN Number
    P000039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION FOR: D10, G4, G7, H2, H3, H6, AND H10. THE REPORTED EVENT OF DEVICE DEFORMATION COULD NOT BE CONFIRMED. THE INVESTIGATION CONFIRMED THE DEVICE MET VISUAL AND FUNCTIONAL SPECIFICATIONS WHEN ANALYZED AT ABBOTT. 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 INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION REGARDING THIS EVENT HAS BEEN REQUESTED. THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN A SUBSEQUENT SUBMISSION.

    Description of Event or Problem · 1

    ON (B)(6) 2020, A 12MM AMPLATZER SEPTAL OCCLUDER(LOT#7161276) WAS SELECTED FOR IMPLANT IN THE PATIENT. DURING THE PROCEDURE THE DEVICE FORMED INTO A COBRA SHAPE WHILE INSIDE THE PATIENT. THE DEVICE WAS REMOVED FROM THE PATIENT AND EXCHANGED FOR A NEW 12MM AMPLATZER SEPTAL OCCLUDER(LOT#7190317). THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821607 AMPLATZER SEPTAL OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV AGA MEDICAL CORPORATION 9-ASD-012 7161276 00811806010090

    Patients

    Seq Age Sex Outcome Treatment
    1