BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE HELEX SEPTAL OCCLUDER

    MDR report key: 2851162 · Received November 27, 2012

    Report

    Report Number
    2017233-2012-00789
    Event Type
    Injury
    Date Received
    November 27, 2012
    Date of Event
    August 1, 2012
    Report Date
    October 29, 2012
    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

    THE DEVICE IS UNAVAILABLE AND THEREFORE AN ENGINEERING EVAL CANNOT BE PERFORMED. THE DEVICE LOT NUMBER IS UNAVAILABLE AND THEREFORE, A REVIEW OF THE MFG RECORDS CANNOT BE PERFORMED. LITERATURE CITATION: HEINISCH C. ET.AL. PERCUTANEOUS CLOSURE OF THE PATENT FORAMEN OVALE USING THE HELEX SEPTAL OCCLUDER: ACUTE AND LONG-TERM RESULTS IN 405 PTS. EUROINTERVENTION 2012;8:717-723.

    Description of Event or Problem · 1

    THIS INFO WAS RECEIVED THROUGH LITERATURE ARTICLE "PERCUTANEOUS CLOSURE OF THE PATENT FORAMEN OVALE USING THE HELEX SEPTAL OCCLUDER: ACUTE AND LONG-TERM RESULTS IN 405 PTS" PUBLISHED IN EUROINTERVENTION, 2012. IT WAS REPORTED THE PHYSICIAN IMPLANTED A GORE HELEX SEPTAL OCCLUDER TO CLOSE A PATENT FORAMEN OVALE. SEVENTEEN MONTHS FOLLOWING IMPLANT, THE PT UNDERWENT SURGICAL CLOSURE OF THE DEFECT DUE TO A PERSISTENT SHUNT.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other