BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER CRIBRIFORM OCCLUDER

    MDR report key: 7961830 · Received October 12, 2018

    Report

    Report Number
    2135147-2018-00181
    Event Type
    Injury
    Date Received
    October 12, 2018
    Date of Event
    October 1, 2018
    Report Date
    November 8, 2018
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    UDI-DI
    00811806010298
    PMA / PMN Number
    P000039/S013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2018, DURING THE POSITIONING OF A 25MM AMPLATZER CRIBIFORM OCCLUDER (ACO) THE LEFT DISC DEPLOYED DEFORMED, ASSUMING AN INCORRECT FORM. THE DEVICE WAS NOT RELEASED AND WAS REMOVED FROM THE PATIENT. OUTSIDE THE PATIENT, THE ACO WAS ATTEMPTED TO BE DEPLOYED, BUT CONTINUED TO DEPLOY DEFORMED. A SECOND 25MM AMPLATZER CRIBIFORM OCCLUDER (LOT NUMBER: 6170508) WAS USED AND IMPLANTED SUCCESSFULLY USING THE FIRST DELIVERY SYSTEM. THE PROCEDURE WAS NOT EXTENDED AND PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800212 AMPLATZER CRIBRIFORM OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-MF-025 6251068 00811806010298

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R