BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURASEAL, UNKNOWN

    MDR report key: 13601885 · Received February 25, 2022

    Report

    Report Number
    3003418325-2022-00002
    Event Type
    Injury
    Date Received
    February 25, 2022
    Report Date
    May 2, 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

    DURASEAL 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. HOWEVER, AT THE TIME OF MANUFACTURING, RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS. WITH THE INFORMATION PROVIDED A ROOT CAUSE COULD NOT BE DETERMINED, AS THERE IS NO WAY TO RELIABLY DETERMINE WHY THE REPORTED CONDITION OCCURRED. MOST LIKELY ROOT CAUSE COULD NOT BE DETERMINED, HOWEVER "CSF LEAK" HAS AN ACCEPTABLE RISK OF PERFORMANCE, SOLUTION MIXING AND COVERAGE WITH AN IMPROBABLE OCCURRENCE. 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 3 REPORTS FOUND IN THIS ARTICLE, LINKED TO MFG REPORT NUMBERS: 1121308-2022-00009; 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: DURASEAL ¿ CSF RHINORRHEA- (B)(6) MALE WITH NONFUNCTIONING PITUITARY ADENOMA, TUMOR DIAMETER > 1 CM, DURAL DEFECT 1-3 CM, FAT GRAFT, SPONGOSTAN, AND SUGIFLO ALSO USED IN SURGERY. REVISION SURGERY FOR LUMBAR DRAIN AND DIRECT REPAIR. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2399267 DURASEAL, UNKNOWN DURASEAL CRANIAL GXQ INTEGRA - PRINCETON

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown