BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAGEN DURAL GRAFT MATRIX

    MDR report key: 13601773 · Received February 25, 2022

    Report

    Report Number
    1121308-2022-00009
    Event Type
    Injury
    Date Received
    February 25, 2022
    Report Date
    March 11, 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

    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

    DURAGEN WAS NOT RETURNED FOR EVALUATION; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED, THUS DEVICE HISTORY RECORD (DHR) WAS NOT POSSIBLE AND NO RETAIN SAMPLE EVALUATION COULD BE PERFORMED. CONSEQUENTLY, A ROOT CAUSE DETERMINATION IS NOT POSSIBLE AT THIS TIME. HOWEVER, IT WAS REPORTED THAT IN ADDITION TO DURAGEN, FASCIA LATA GRAFT AND NASOPORE WERE ALSO USED IN THE SURGERY; THE OPERATIVE APPROACH WAS ¿EXPANDED ENDONASAL APPROACH¿ (EEA) AND THAT THE INTRAOPERATIVE CSF LEAK WAS ¿GRADE 3¿ (HIGHEST RANK POSSIBLE) WHICH WAS DEFINED AS ¿LARGE LEAK TYPICALLY CREATED AS A PART OF EEA¿. ¿INTRAOPERATIVE CSF LEAK (ESPECIALLY IF HIGH FLOW)¿ IS LISTED AS ONE OF THE RISK FACTORS INCLUDED IN THE LITERATURE REPORT (¿FINDINGS IN THE CONTEXT OF LITERATURE¿ SECTION) FOR POSTOPERATIVE CSF RHINORRHEA AND THUS A POSSIBLE CONTRIBUTOR FOR THE REPORTED CONDITION. 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 1 OF 3 REPORTS FOUND IN THIS ARTICLE, LINKED TO MFG REPORT NUMBERS: 3003418325-2022-00002; 1121308-2022-00010. WORLD NEUROSURGERY (2021) PUBLISHED AN ARTICLE: "CSF RHINORRHOEA AFTER ENDONASAL INTERVENTION TO THE SKULL BASE (CRANIAL) - PART 1: MULTICENTER PILOT STUDY." BACKGROUND: CRANIAL (CSF RHINORRHOEA AFTER ENDONASAL INTERVENTION TO THE SKULL BASE) IS A PROSPECTIVE MULTICENTER OBSERVATIONAL STUDY SEEKING TO DETERMINE 1) THE SCOPE OF SKULL BASE REPAIR METHODS USED AND 2) CORRESPONDING RATES OF POSTOPERATIVE CEREBROSPINAL FLUID (CSF) RHINORRHEA IN THE ENDONASAL TRANSSPHENOIDAL APPROACH (TSA) AND THE EXPANDED ENDONASAL APPROACH (EEA) FOR SKULL BASE TUMORS. WE SOUGHT TO PILOT THE PROJECT, ASSESSING THE FEASIBILITY AND ACCEPTABILITY BY GATHERING PRELIMINARY DATA. METHODS: A PROSPECTIVE OBSERVATIONAL COHORT STUDY WAS PILOTED AT 12 TERTIARY NEUROSURGICAL UNITS IN THE UNITED KINGDOM. FEEDBACK REGARDING PROJECT POSITIVES AND CHALLENGES WERE QUALITATIVELY ANALYZED. RESULTS: A TOTAL OF 187 CASES WERE INCLUDED: 159 TSA (85%) AND 28 EEA (15%). THE MOST COMMON DISEASES INCLUDED PITUITARY ADENOMAS (N [ 142/187), CRANIOPHARYNGIOMAS (N [ 13/187). AND SKULL BASE MENINGIOMAS (N [ 4/187). THE MOST COMMON SKULL BASE REPAIR TECHNIQUES USED WERE TISSUE GLUES (N [ 132/187, MOST COMMONLY TISSEEL), GRAFTS (N [ 94/187, MOST COMMONLY FAT AUTOGRAFT OR SPONGOSTAN) AND VASCULARIZED FLAPS (N [ 51/187, MOST COMMONLY NASOSEPTAL). THESE REPAIRS WERE MOST FREQUENTLY SUPPORTED BY NASAL PACKS (N [ 125/187) AND LUMBAR DRAINS (N [ 20/187). BIOCHEMICALLY CONFIRMED CSF RHINORRHEA OCCURRED IN 6/159 PATIENTS UNDERGOING TSA (3.8%) AND 2/28 PATIENTS UNDERGOING EEA (7.1%). FOUR PATIENTS UNDERGOING TSA (2.5%) AND 2 PATIENTS UNDERGOING EEA (7.1%) REQUIRED OPERATIVE MANAGEMENT FOR CSF RHINORRHEA (CSF DIVERSION OR DIRECT REPAIR). QUALITATIVE FEEDBACK WAS LARGELY POSITIVE (THEMES INCLUDED USER-FRIENDLY AND EFFICIENT DATA COLLECTION AND STRONG SUPPORT FROM SENIOR TEAM MEMBERS), DEMONSTRATING ACCEPTABILITY. ADVERSE EVENT: DURAGEN - CSF RHINORRHEA ¿ (B)(6) FEMALE WITH LUNG METASTASIS, TUMOR DIAMETER > 1CM, DURAL DEFECT NOT RECORDED, GRADE 3 INTRAOPERATIVE CSF LEAK. FASCIA LATA GRAFT AND NASOPORE ALSO USED IN SURGERY. REVISION SURGERY FOR LUMBAR DRAIN. CONCLUSIONS: OUR PILOT EXPERIENCE HIGHLIGHTS THE ACCEPTABILITY AND FEASIBILITY AND SCALABILITY IN THE CRANIAL PROJECT PROCEDURES. THERE IS A PRECEDENT FOR MULTICENTER DISSEMINATION OF THIS PROJECT, TO ESTABLISH A BENCHMARK OF CONTEMPORARY PRACTICE IN SKULL BASE NEUROSURGERY, PARTICULARLY WITH RESPECT TO PATIENTS UNDERGOING EEA. HTTPS://DOI.ORG/10.1016/J.WNEU.2020.12.171.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1333594 DURAGEN DURAL GRAFT MATRIX N/A GXQ INTEGRA - PRINCETON

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown