BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE HELEX SEPTAL OCCLUDER

    MDR report key: 1668501 · Received April 22, 2010

    Report

    Report Number
    2017233-2010-00183
    Event Type
    Injury
    Date Received
    April 22, 2010
    Date of Event
    November 9, 2006
    Report Date
    April 22, 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

    A REVIEW OF THE MANUFACTURING RECORDS HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING RECORDS VERIFIED THAT THE DEVICE WAS RELEASED IN ACCORDANCE WITH GORE'S QUALITY SYSTEM REQUIREMENTS. THE DEVICE REMAINS IMPLANTED SO NO ENGINEERING EVALUATION COULD BE CONDUCTED. 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 25MM HELEX SEPTAL OCCLUDER ON (B) (6) 2005 TO CLOSE A 12.8MM PATENT FORAMEN OVALE. A MODERATE RESIDUAL SHUNT WAS NOTED DURING A FOLLOW UP VISIT. ON (B) (6) 2006, A REINTERVENTION WAS PERFORMED AND A 25MM OCCLUDER WAS IMPLANTED THEREBY CLOSING THE DEFECT WITH NO PROCEDURAL COMPLICATIONS.

    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 03771535

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other