BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER CRIBRIFORM OCCLUDER

    MDR report key: 8538080 · Received April 22, 2019

    Report

    Report Number
    2135147-2019-00116
    Event Type
    Injury
    Date Received
    April 22, 2019
    Date of Event
    April 3, 2019
    Report Date
    May 14, 2019
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    UDI-DI
    00811806010304
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE CAUSE OF THE INITIAL BULBOUS SHAPE COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    ON (B)(6) 2019, A 30MM AMPLATZER CRIBRIFORM OCCLUDER WAS SELECTED FOR IMPLANT. DURING THE PROCEDURE, THE LEFT AND RIGHT ATRIAL DISCS OF THE DEVICE DEPLOYED IN A SOMBRERO FORMATION. THE DEVICE WAS RECAPTURED AND EXCHANGED FOR A SMALLER SIZE DEVICE. A 25MM AMPLATZER PFO OCCLUDER WAS IMPLANTED WITHOUT DIFFICULTY AND THERE WAS NO DEFORMATION. THE PATIENT SUSTAINED NO ADVERSE OUTCOMES OR CONSEQUENCES PER REPORTED.

    Description of Event or Problem · 1

    ON (B)(6) 2019, A 30MM AMPLATZER CRIBRIFORM OCCLUDER WAS SELECTED FOR IMPLANT. DURING THE PROCEDURE, THE LEFT AND RIGHT ATRIAL DISCS OF THE DEVICE DEPLOYED IN A SOMBRERO FORMATION. THE DEVICE WAS RECAPTURED AND EXCHANGED FOR A SMALLER SIZE DEVICE. A 25MM AMPLATZER PFO OCCLUDER (LOT NUMBER: 6803298 ) WAS IMPLANTED WITHOUT DIFFICULTY AND THERE WAS NO DEFORMATION. THE PATIENT SUSTAINED NO ADVERSE OUTCOMES OR CONSEQUENCES PER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328462 AMPLATZER CRIBRIFORM OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV AGA MEDICAL CORPORATION 9-ASD-MF-030 6760703 00811806010304

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R