BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE HELEX SEPTAL OCCLUDER

    MDR report key: 1140234 · Received August 29, 2008

    Report

    Report Number
    2017233-2008-00532
    Event Type
    Injury
    Date Received
    August 29, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 27, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES, INC
    Product Code
    MLV
    PMA / PMN Number
    P050006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. INCORRECT SIZE/SELECTED OCCLUDER IS TOO SMALL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN IMPLANTED A HELEX SEPTAL OCCLUDER IN 2008, TO CLOSE A PFO (PATENT FORAMEN OVALE). A 20MM DEVICE WAS IMPLANTED WITH NO BALLOON SIZING. THE PATIENT HAD AN UNRELATED ABDOMINAL CT THE FOLLOWING MONTH. DURING THE EXAM IT WAS DISCOVERED THAT THE OCCLUDER WAS SNARED OUT AND A COMPETITOR DEVICE WAS IMPLANTED. THE EXPLANTED DEVICE WAS DISCARDED. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE HELEX SEPTAL OCCLUDER NONE MLV W.L. GORE & ASSOCIATES, INC WLG216 05221986

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization