BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® PRECLUDE® PDX DURA SUBSTITUTE

    MDR report key: 24818621 · Received April 8, 2026

    Report

    Report Number
    3007284313-2026-04694
    Event Type
    Injury
    Date Received
    April 8, 2026
    Date of Event
    November 8, 2002
    Report Date
    April 8, 2026
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    GXQ
    PMA / PMN Number
    K953969
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    W. L. GORE & ASSOCIATES, INC. RECEIVED INFORMATION VIA A LEGAL COMPLAINT ALLEGING THAT A GORE® PRECLUDE® PDX DURA SUBSTITUTE (MODEL 1PDX302) FAILED TO PROVIDE A WATERTIGHT DURAL SEAL, RESULTING IN POSTOPERATIVE CEREBROSPINAL FLUID LEAKAGE. ACCORDING TO THE COMPLAINT, THE PATIENT REQUIRED A SUBSEQUENT SURGICAL PROCEDURE DURING WHICH THE DEVICE WAS EXPLANTED. THE EVENT WAS REPORTED MORE THAN 20 YEARS AFTER IMPLANTATION AND WAS NOT REPORTED BY A HEALTHCARE PROFESSIONAL. H6 - B22: THE DEVICE IS NOT AVAILABLE FOR EVALUATION, AND NO LOT OR SERIAL NUMBER INFORMATION WAS PROVIDED. 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

    IT WAS REPORTED VIA A LEGAL COMPLAINT THAT A GORE® PRECLUDE® PDX DURA SUBSTITUTE (MODEL 1PDX302) WAS IMPLANTED DURING CRANIAL SURGERY IN APPROXIMATELY (B)(6) 2002 FOR DURAL REPAIR. THE COMPLAINT ALLEGES THAT THE DEVICE FAILED TO PROVIDE A WATERTIGHT DURAL SEAL, RESULTING IN POSTOPERATIVE CEREBROSPINAL FLUID (CSF) LEAKAGE, ALLEGEDLY ASSOCIATED WITH SUTURE-LINE PATHWAYS AND GAPS BETWEEN THE DEVICE AND NATIVE DURA. DUE TO ONGOING CSF LEAKAGE, THE DEVICE WAS REPORTEDLY SURGICALLY REMOVED DURING A SUBSEQUENT PROCEDURE IN APPROXIMATELY (B)(6) 2002. THIS INFORMATION IS BASED SOLELY ON ALLEGATIONS CONTAINED IN A LEGAL FILING. NO HEALTHCARE PROFESSIONAL DIRECTLY REPORTED THE EVENT. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436162 GORE® PRECLUDE® PDX DURA SUBSTITUTE DURA SUBSTITUTE GXQ W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R PRODUCT: DURAGEN DURAL SUBSTITUTEMANUFACTURER: I.