BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE HELEX SEPTAL OCCLUDER

    MDR report key: 1667625 · Received April 23, 2010

    Report

    Report Number
    2017233-2010-00190
    Event Type
    Injury
    Date Received
    April 23, 2010
    Date of Event
    February 1, 2010
    Report Date
    April 23, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MLV
    PMA / PMN Number
    P050006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - A REVIEW OF THE MFG RECORDS COULD NOT BE CONDUCTED BECAUSE, THE LOT# IS UNAVAILABLE. THE DEVICE REMAINS IMPLANTED, SO NO ENGINEERING EVAL COULD BE CONDUCTED. THE HOSPITAL DOES NOT HAVE A RECORD, MATCHING THE PT DETAILS IN THE ARTICLE SO NO FURTHER INFO IS AVAILABLE. MAJUNKE N, WALLENBORN J, BARANOWSKI A, WUNDERLICH N, SIEVERT H. DEVICE CLOSURE OF RESIDUAL SHUNT AFTER PERCUTANEOUS CLOSURE OF PATENT FORAMEN OVALE. EUROINTERVENTION 2010;5(7):833-837.

    Description of Event or Problem · 1

    THE EVENT WAS RECEIVED THROUGH LITERATURE ARTICLE "DEVICE CLOSURE OF RESIDUAL SHUNT AFTER PERCUTANEOUS CLOSURE OF PATENT FORAMEN OVALE" PUBLISHED IN EUROINTERVENTION 2010. IT WAS REPORTED THAT THE PHYSICIAN IMPLANTED A 15MM HELEX SEPTAL OCCLUDER TO CLOSE A 5MM PATENT FORAMEN OVALE. THE PT EXPERIENCED A TRANSIENT WEAKNESS OF LEFT ARM FOLLOWED BY TRANSIENT GLOBAL AMNESIA FOUR YEARS POST IMPLANT. A LARGE RESIDUAL SHUNT WAS NOTED DURING A FOLLOW UP VISIT. A REINTERVENTION WAS PERFORMED AND A 30MM OCCLUDER WAS IMPLANTED THEREBY CLOSING THE DEFECT WITH NO PROCEDURAL COMPLICATIONS. THERE HAVE BEEN NO FURTHER THROMBOEMBOLIC EVENTS AFTER THE DEFECT WAS CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE HELEX SEPTAL OCCLUDER MLV / OCCLUDER, TRANSCATHETER SEPTAL MLV W.L. GORE & ASSOCIATES WLG216

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other