BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAGEN DURAL GRAFT MATRIX

    MDR report key: 13965994 · Received March 31, 2022

    Report

    Report Number
    1121308-2022-00022
    Event Type
    Injury
    Date Received
    March 31, 2022
    Report Date
    April 21, 2022
    Manufacturer
    INTEGRA - PRINCETON
    Product Code
    GXQ
    PMA / PMN Number
    K982180
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE DURAGEN DURAL GRAFT MATRIX (DURAGEN) WAS NOT RETURNED FOR EVALUATION AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED. AS PER SCIENTIFIC AFFAIRS ASSESSMENT: ¿A TRANS CLIVUS PROCEDURE IS A RARE EVENT AND DONE FOR TUMORS OF THE ANTERIOR SURFACE OF THE BRAINSTEM OR CEREBELLUM. THE TRANSPHENOIDAL APPROACH THAT PASSES THROUGH THE CLIVUS GIVES ACCESS TO THE ANTERIOR STRUCTURES OF THE POSTERIOR FOSSA. THIS IS AN EXTREMELY COMPLICATED AND INVOLVED PROCEDURE. PARTICULARLY FOR DURAL CLOSURE. AS IS IT HARD TO PROVIDE OVERLYING TAMPONADE OF THE DURAGEN TO HOLD IT IN PLACE. THE FEW SMALL LEAKS ARE IN FACT A SIGNIFICANT ACHIEVEMENT AND I WOULD NOT CONSIDER IT AN ADVERSE EVENT, JUST AN EXPECTED CONSEQUENCE FOR THE PROCEDURE.¿ THEREFORE, THE MOST PROBABLE CAUSE IS THAT THE LEAKS ARE MOST PROBABLY CAUSED DUE TO PROCEDURE COMPLICATIONS AND NOT NECESSARILY FROM PRODUCT FAILURE. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 0

    THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBER 1121308-2022-00021: THIS REPORT IS FROM A SPEECH AT (B)(6) NEUROSURGICAL SOCIETY HELD ON (B)(6) 2022 TITLED "NASAL ENDOSCOPIC SURGERY: CAN CEREBROSPINAL FLUID LEAKAGE BE PREVENTED WITHOUT THE USE OF FAT OR FASCIA?" IT WAS REPORTED THAT FROM OCTOBER 2019 TO OCTOBER 2021, 56 CASES OF TRANSNASAL ENDOSCOPIC SURGERY WITH SADDLE BOTTOM FORMATION WERE INCLUDED. OF THE CASES, TWO (2) HAD POSTOPERATIVE CEREBROSPINAL FLUID (CSF) LEAKAGE WHICH OCCURRED WHEN DURAGEN WAS PLACED IN CLIVUS. THE AMOUNT OF CSF LEAK WAS UNKNOWN. RE-OPERATIONS WERE PERFORMED, AND FISTULA WERE OBSERVED ON CLIVUS IN BOTH CASES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1345671 DURAGEN DURAL GRAFT MATRIX N/A GXQ INTEGRA - PRINCETON

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown