BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® PRECLUDE® DURA SUBSTITUTE

    MDR report key: 18039228 · Received October 31, 2023

    Report

    Report Number
    3007284313-2023-02861
    Event Type
    Injury
    Date Received
    October 31, 2023
    Date of Event
    July 20, 2022
    Report Date
    October 31, 2023
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    GXQ
    PMA / PMN Number
    K953969
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    W. L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE A LEGAL ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR HAS MALFUNCTIONED, AS DEFINED FROM A LEGAL STANDPOINT. THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    THE FOLLOWING PUBLISHMENT WAS REVIEWED BY GORE: TITLE: EXTENSION OF THE PREEXISTING INTRAMURAL POUCH IN THE VENTRAL DURA FOLLOWING REPAIR FOR IDIOPATHIC SPINAL CORD HERNIATION. SOURCE: JOURNAL OF SPINE RESEARCH VOL. 13, NO. 7, 2022. P.981-986. CASE REPORT: A 57-YEAR-OLD MAN PRESENTED WITH BROWN-SÉQUARD SYNDROME. MAGNETIC RESONANCE IMAGING (MRI) REVEALED IDIOPATHIC SPINAL CORD HERNIATION (ISCH) AT THE T4/5 LEVEL. INTRAOPERATIVELY, WE OBSERVED HERNIATION OF THE SPINAL CORD INTO AN INTRAMURAL POUCH BETWEEN THE DUPLICATED VENTRAL DURA MATER. WE RELEASED AND REPAIRED THE HERNIA USING AN EXPANDED POLYTETRAFLUOROETHYLENE (EPTFE) SHEET, GORE® PRECLUDE® DURA SUBSTITUTE (DURA). THE PATIENT¿S SYMPTOMS WORSENED BY THE 7TH MONTH POSTOPERATIVELY, AND MRI REVEALED ECTOPIC CEREBROSPINAL FLUID (CSF) POOLING AT THE VENTRAL ASPECT OF THE SPINAL CANAL FROM THE CERVICAL TO LUMBAR LEVELS. DURING RE-OPERATION, WHEN THE DURA COVERED WITH ADHESIONS WAS REMOVED WE IDENTIFIED A WIDE CAVITY THROUGH THE DURAL DEFECT. INTRAOPERATIVE FINDINGS CONFIRMED EXTENSION OF THE PRE-EXISTING INTRAMURAL POUCH THAT ENCOMPASSED ALL SPINAL LEVELS. CONCLUSIONS: MEMBRANOUS ADHESION SECONDARY TO THE DURA MAY FUNCTION AS A ONE-WAY VALVE ON THE PULSATILE CSF AND RESULT IN THE AFOREMENTIONED COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1882200 GORE® PRECLUDE® DURA SUBSTITUTE DURA SUBSTITUTE GXQ W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Other