BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE PRECLUDER MVP DURA SUBSTITUTE

    MDR report key: 2482403 · Received February 27, 2012

    Report

    Report Number
    2017233-2012-00127
    Event Type
    Injury
    Date Received
    February 27, 2012
    Date of Event
    December 7, 2006
    Report Date
    January 31, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    GXQ
    PMA / PMN Number
    K021477
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A PROCEDURE IN 2006 FOR CHIARI MALFORMATION. A GORE PRECLUDE (B)(4) DEVICE WAS REPORTED TO BE IMPLANTED. TWO WEEKS AFTER THE PROCEDURE, THE PT REPORTED DEVELOPING MENINGITIS. THE PT CONSULTED A SECOND NEUROSURGEON AND A PROCEDURE TO REMOVE THE PATCH WAS PERFORMED. THE SURGEON'S FINDINGS CONCLUDED THAT REMOVING THE PATCH WOULD NOT BE OF BENEFIT, AND THE PATCH WAS LEFT IN PLACE. MEDICAL RECORDS FROM (B)(6) HOSPITAL REVEALED THE FOLLOWING SURGICAL INTERVENTIONS: ON (B)(6) 2006, POSTERIOR FOSSA CRANIECTOMY; C1 LAMINECTOMY AND DURAPLASTY. THE PT'S PREOPERATIVE DIAGNOSIS WAS CHIARI1 MALFORMATION WITH SYRINGOMELIA. ON (B)(6) 2007, SUBOCCIPITAL WOUND REVISION; STENT PLACEMENT 4TH VENTRICLE OF CERVICAL SUBARACHNOID. SPACE; RE-SUTURING OF DURAL PATCH. THE PT'S PREOPERATIVE DIAGNOSIS WAS SUBOCCIPITAL PSEUDOMENINGOCELE. AEROBIC AND ANAEROBIC CULTURES WERE TAKEN OF THE CEREBRAL SPINAL FLUID BEFORE AND DURING THE SECOND PROCEDURE. NO ORGANISMS WERE SEEN IN THE FINAL REPORTS. THERE IS NO REFERENCE TO MENINGITIS IN THESE REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE PRECLUDER MVP DURA SUBSTITUTE GXQ/ DURA SUBSTITUTE GXQ W.L. GORE & ASSOCIATES WLG102 03126831

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Other DURASEAL SEALANT