BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZER CRIBRIFORM OCCLUDER

    MDR report key: 9262243 · Received October 31, 2019

    Report

    Report Number
    2135147-2019-00341
    Event Type
    Malfunction
    Date Received
    October 31, 2019
    Date of Event
    October 10, 2019
    Report Date
    December 9, 2019
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    UDI-DI
    00811806010304
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF A DEFORMED DEPLOYMENT WAS CONFIRMED. FOLLOWING THE SIMULATED DEPLOYMENT, THE BULBOUS SHAPE RETURNED TO NORMAL AND MET 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 DEFINED MANUFACTURING SPECIFICATIONS AT THE TIME OF RELEASE TO COMMERCIALIZATION. THOUGH THE OCCLUDER WAS DETERMINED TO MEET FUNCTIONAL SPECIFICATIONS, THE ROOT CAUSE OF THE DEFORMATION UPON INITIAL DEPLOYMENT IS UNDER FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2019, A 30MM AMPLATZER CRIBRIFORM OCCLUDER (LOT 7072146) WAS SELECTED FOR IMPLANT. WHILE ATTEMPTING TO DEPLOY THE DEVICE ACROSS THE DEFECT, THE LEFT DISC DEPLOYED DEFORMED, BOMBED. THE DEVICE WAS REMOVED FROM THE PATIENT AND EXCHANGED FOR ANOTHER 30MM AMPLATZER CRIBRIFORM OCCLUDER (LOT NUMBER: 7032154). THE SECOND DEVICE WAS SUCCESSFULLY IMPLANTED WITH NO FURTHER ISSUE REPORTED.

    Description of Event or Problem · 1

    ON (B)(6) 2019, A 30MM AMPLATZER CRIBRIFORM OCCLUDER WAS SELECTED FOR IMPLANT. WHILE ATTEMPTING TO DEPLOY THE DEVICE ACROSS THE DEFECT, THE LEFT DISC DEPLOYED DEFORMED IN A "BOMBED" FORMATION. THE DEVICE WAS REMOVED FROM THE PATIENT AND EXCHANGED FOR ANOTHER 30MM AMPLATZER CRIBRIFORM OCCLUDER (LOT NUMBER: 7032154). THE SECOND DEVICE WAS SUCCESSFULLY IMPLANTED WITH NO FURTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1057449 AMPLATZER CRIBRIFORM OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV AGA MEDICAL CORPORATION 9-ASD-MF-030 7072146 00811806010304

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention