BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER PFO OCCLUDER

    MDR report key: 7949075 · Received October 9, 2018

    Report

    Report Number
    2135147-2018-00173
    Event Type
    Injury
    Date Received
    October 9, 2018
    Date of Event
    September 18, 2018
    Report Date
    December 29, 2018
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P120021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    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, A 25MM AMPLATZER PFO OCCLUDER (PFO) WAS SELECTED FOR IMPLANT WITH AN 8F AMPLATZER TORQVUE DELIVERY SYSTEM BUT WAS NOT RELEASED AS THE OCCLUDER WAS TOO SMALL. A 30MM AMPLATZER PFO OCCLUDER (LOT NUMBER: 6234048) WAS SELECTED, BUT AND DURING DEPLOYMENT, THE DEVICE DEPLOYED DEFORMED, CUP SHAPED. MULTIPLE FAILED ATTEMPTS WERE MADE TO RECAPTURE AND REPOSITION THE DEVICE, BUT THE DEVICE CONTINUED TO BE DEFORMED. THE DEVICE WAS REMOVED AND EXCHANGED FOR ANOTHER 30MM AMPLATZER PFO OCCLUDER (LOT NUMBER: 6300749). THE SECOND 30MM PFO DEPLOYED DEFORMED AS WELL, AND THE USER REPORTED THE PROBLEM WAS DUE TO A MANUFACTURING DEFECT. THE SECOND 30MM PFO WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A 35MM AMPLATZER PFO OCCLUDER (LOT NUMBER: 4084486) IMPLANTED SUCCESSFULLY. THE PROCEDURE WAS EXTENDED GREATER THAN 30 MINUTES; HOWEVER, THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788096 AMPLATZER PFO OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-PFO-030 6300749

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R