BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER PFO OCCLUDER

    MDR report key: 6257442 · Received January 17, 2017

    Report

    Report Number
    2135147-2017-00008
    Event Type
    Injury
    Date Received
    January 17, 2017
    Date of Event
    December 13, 2016
    Report Date
    December 20, 2016
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P120021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. OUR INVESTIGATION WAS LIMITED TO THE REVIEW OF THE DEVICE HISTORY RECORD, WHICH SHOWED THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND INDICATED COMPLETE IN ACCORDANCE WITH SJM SPECIFICATIONS AND PROCEDURES. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE AMPLATZER PFO OCCLUDER (PFO) WAS IMPLANTED IN THE PATIENT'S LARGE PFO WITH AN ANEURYSMAL SEPTUM. THE PFO WAS POSITIONED AND SEVERAL STABILITY TESTS WERE PERFORMED BEFORE RELEASE. THE PATIENT WAS DISCHARGED TO HOME ON THE SAME DAY. HEMOSTASIS HAD BEEN ACHIEVED; HOWEVER, AFTER LEAVING THE HOSPITAL THE PATIENT TRAVELLED 2-3 HOURS HOME. THAT EVENING THE PATIENT WENT TO ANOTHER HOSPITAL AND WAS TREATED FOR A GI BLEED. THERE WAS CONCERN BY THE CONSULTANTS THAT THE PFO DEVICE EMBOLIZED SECONDARY TO A VALSALVA MANEUVER AT THIS TIME. ON (B)(6) 2016, THE PATIENT PRESENTED FOR A FOLLOW-UP TOE POST PFO CLOSURE. THE PFO WAS DIFFICULT TO IMAGE, BUT A LEFT TO RIGHT STUNT WAS REVEALED. A CHEST X-RAY CONFIRMED THE PFO HAD EMBOLIZED IN THE PATIENT'S PA. THE PATIENT WAS PLACED ON APIXOBAHN. ON (B)(6) 2016, SURGERY WAS PERFORMED TO REMOVE THE PFO AND CLOSE THE PATIENT'S PFO. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40998 AMPLATZER PFO OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-PFO-025 5148783

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R