BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER PFO OCCLUDER

    MDR report key: 9813728 · Received March 10, 2020

    Report

    Report Number
    2135147-2020-00069
    Event Type
    Injury
    Date Received
    March 10, 2020
    Date of Event
    February 17, 2020
    Report Date
    March 10, 2020
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    UDI-DI
    00811806011288
    PMA / PMN Number
    P120021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT OF EMBOLISM 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. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    DURING A PFO PROCEDURE, A 9-PFO-025 (LOT. 7270612) WAS PLACED WITH DELIVERY 9-ITV09F45/80 (LOT. 7218636). FOLLOWING VERIFICATION OF THE CORRECT POSITIONING OF THE DEVICE, THE DEVICE WAS RELEASED. AFTER THE RELEASE THE RIGHT DISC CROSSED THE SEPTUM SECUNDUM. IT WAS THEREFORE DECIDED TO RECAPTURE THE DEVICE WITH A 35MM GOOSE NECK. ONCE HOOKED THE DEVICE WITH THE GOOSE NECK THE HOOKED THE DEVICE MIGRATED TO THE LEFT ATRIUM AND AFTER A SHORT TIME IT LOST CONTACT WITH THE GOOSE NECK AND MIGRATED TO THE DESCENDING AORTA. A RIGHT FEMORAL ARTERY ACCESS WAS THEN TAKEN, A 9-ITV12F45/80 (LOT. 6284858) WAS INSERTED. WITH A 35MM GOOSE NECK THE DEVICE WAS RECAPTURED AND IT WAS BROUGHT IN THE DELIVERY SHEATH AND REMOVED BY THE PATIENT. THE PFO WAS THEN CLOSED BY POSITIONING A 9-PFO-035 (LOT. 7241144) WITH DELIVERY 9-ITV09F45/80 (LOT. 7218636). FOLLOWING VERIFICATION OF THE CORRECT POSITIONING OF THE DEVICE, THE DEVICE WAS RELEASED. FOLLOWING RELEASE, THE DEVICE WAS CORRECTLY POSITIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275572 AMPLATZER PFO OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV AGA MEDICAL CORPORATION 9-PFO-025 7270612 00811806011288

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention