BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER PFO OCCLUDER

    MDR report key: 8798970 · Received July 17, 2019

    Report

    Report Number
    2135147-2019-00207
    Event Type
    Injury
    Date Received
    July 17, 2019
    Date of Event
    June 19, 2019
    Report Date
    July 17, 2019
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P120021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT OF A DEFORMED OCCLUDER WAS REPORTED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND THE PRODUCT MET ALL SPECIFICATIONS AT THE TIME OF COMMERCIALIZATION. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED, HOWEVER, PER THE SITE THE DEVICE RETURNED TO ITS CORRECT CONFORMATION EX-VIVO AND THE PATIENT HAD A LONG PFO TUNNEL.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REPORT NUMBER: 2135147-2019-00206. ON (B)(6) 2019, A 30MM AMPLATZER PFO OCCLUDER WAS SELECTED FOR IMPLANT. WHEN THE DEVICE WAS DEPLOYED AND MADE CONTACT WITH THE SEPTUM THE LA DISC TOOK THE SHAPE OF A "WINE GLASS" AND DIDN'T LAY FLAT. THE DEVICE WAS RECAPTURED AND REPLACED WITH ANOTHER 30MM PFO (LOT: 6570240). THE DEVICE WAS DEPLOYED BUT THE ISSUE RE-OCCURRED. EX-VIVO THE DEVICE RETURNED TO THE EXPECTED SHAPE. A THIRD 30MM PFO (LOT: 6953786) WAS SELECTED, DEPLOYED, AND WAS IMPLANTED SUCCESSFULLY. THE PATIENT REMAINED HEMODYNAMICALLY STABLE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THE USER ATTRIBUTED THE DEFORMATION TO THE PATIENT'S ANATOMY WITH A LONG PFO TUNNEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592085 AMPLATZER PFO OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-PFO-030 6570240

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention AMPLATZER PFO OCCLUDER