BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE PRECLUDE MVP DURA SUBSTITUTE

    MDR report key: 1332689 · Received February 28, 2009

    Report

    Report Number
    2017233-2009-00123
    Event Type
    Injury
    Date Received
    February 28, 2009
    Date of Event
    January 1, 2009
    Report Date
    February 27, 2009
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    GXQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT AVAILABLE FOR EVAL. ATTEMPTING TO OBTAIN ADDITIONAL INFO. LITERATURE CITATION: CHAPPELL, E.T., PARE, L., SALEHPOUR, M., MATTHEWS, M., MIDDLEHOF, C. "GORE PRECLUDE MVP DURA SUBSTITUTE APPLIED AS A NONWATERTIGHT 'UNDERLAY' GRAFT FOR CRANIOTOMIES: PRODUCT AND TECHNIQUE EVAL." SURGICAL NEUROLOGY 71 (2009) 126-129.

    Description of Event or Problem · 1

    IN EARLY 2009, A GORE ASSOCIATE BECAME AWARE OF A PUBLISHED STUDY INVOLVING THE USE OF GORE PRECLUDE MVP DURA SUBSTITUTE (MVP). A SERIES OF SUBJECTS UNDERGOING CRANIOTOMY HAD THEIR DURA RECONSTRUCTED USING A NONWATERTIGHT UNDERLAY GRAFTING TECHNIQUE WITH MVP. IT WAS DETERMINED FROM THE ARTICLE THAT FOUR OF THE STUDY SUBJECTS "EXPERIENCED WOUND DEHISCENCE OR MORE ADVANCED INFECTIONS THAT REQUIRED FURTHER SURGERY." TWO OF THOSE FOUR SUBJECTS REQUIRED REMOVAL OF THE MVP DUE TO INFECTION. OF THESE FOUR SUBJECTS, IT IS UNK AT THIS TIME THE EXACT NUMBER OF INFECTIONS VERSUS WOUND DEHISCENCE. NONE OF THE COMPLICATIONS IN THE STUDY WERE DIRECTLY ATTRIBUTED TO THE USE OF MVP, BUT RATHER WERE ATTRIBUTED TO THE SURGICAL UNDERLAY TECHNIQUE USED. GORE IS CURRENTLY ATTEMPTING TO OBTAIN ADDITIONAL INFO FROM THE STUDY SITE AND/OR STUDY PHYSICIAN (PI).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE PRECLUDE MVP DURA SUBSTITUTE NONE GXQ W.L. GORE & ASSOCIATES WLG102

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention