BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAGEN 4X5 1 PACK CE

    MDR report key: 19760659 · Received July 17, 2024

    Report

    Report Number
    1121308-2024-00031
    Event Type
    Injury
    Date Received
    July 17, 2024
    Report Date
    August 30, 2024
    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

    DURAGEN ((B)(6)) 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. INVESTIGATION FINDINGS: DURAGEN WAS NOT RETURNED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. SINCE NO LOT NUMBER WAS PROVIDED AS PART OF THE COMPLAINT REPORT, THE DEVICE HISTORY RECORD (DHR) WAS NOT POSSIBLE AND NO RETAIN SAMPLE EVALUATION COULD BE PERFORMED. HOWEVER, A MEDICAL ASSESSMENT WAS PERFORMED WHICH CONCLUDED THE FOLLOWING: ¿BASED ON THE COMPLAINT INFORMATION RECEIVED TO DATE, THERE IS INSUFFICIENT EVIDENCE TO SUGGEST THAT THE DURAGEN PRODUCT WAS CAUSAL TO THE EPIDURAL HEMATOMA, AS IT APPEARS TO BE PROCEDURALLY RELATED. SURGEONS SHALL DETERMINE, BASED ON THE PATIENT¿S UNDERLYING MEDICAL CONDITION AND SURGERY NEEDED, WHAT PRODUCTS OR INSTRUMENTATION TO USE AND THE SURGICAL TECHNIQUE APPROACH TAKEN FOR OPTIMAL RESULTS. IN THIS PARTICULAR CASE, IT WAS REPORTED THAT ¿THE DOCTOR ASSUMED THAT NOT BEING ABLE TO PLACE TENTING SUTURE MAY POSSIBLY BE THE CAUSE OF THE EVENT¿. NO ADDITIONAL INFORMATION REGARDING THE PATIENT¿S OTHER RELEVANT MEDICAL HISTORY, INTRA-OPERATIVE PROCEDURES NOTES, AND PATIENT POST-OPERATIVE CARE WERE PROVIDED BY THE CUSTOMER. BASED ON THE PRODUCT¿S INSTRUCTIONS FOR USE (IFU), DURAGEN IS AN ONLAY GRAFT AND DOES NOT REQUIRE SUTURES. HOWEVER, IF DESIRED, ATRAUMATIC STAY SUTURES MAY BE UTILIZED, BUT AS A PRECAUTION, TENSIONLESS SUTURING TECHNIQUE MUST BE USED TO PREVENT TEARING THE DURAGEN. IN ADDITION, CLOSED SUCTION DRAINAGE IS SUGGESTED FOR 1 TO 3 DAYS POSTOPERATIVELY. ACCORDING TO PRZEPIÓRKA ET AL., DURAL TENTING IS A WELL-KNOWN METHOD OF SUTURING THE DURA TO THE BONE OR PERICRANIUM AFTER CRANIOTOMY. THIS DECREASES THE EXTRADURAL SPACE WHERE EXTRADURAL HEMORRHAGE (EDH) COULD DEVELOP AND COMPRESS DURAL VESSELS, WHICH ARE POSSIBLE SOURCES OF EDH. HOWEVER, THE CURRENT NEED FOR DURAL TENTING SUTURES IN CONTEMPORARY NEUROSURGICAL PRACTICE HAS BEEN EXAMINED IN THE LITERATURE FOR YEARS. PREVIOUSLY, THESE TENSION SUTURES WERE INTENDED TO PREVENT BLOOD COLLECTING IN THE POTENTIAL SPACE BETWEEN THE SKULL AND THE DURA. IN THEORY, WITH MODERN HEMOSTASIS AND PROPER POSTOPERATIVE CARE, THIS TECHNIQUE SHOULD NOT BE NEEDED, AND THE SURGERY TIME CAN BE SHORTENED. UNFORTUNATELY, THERE IS NO EVIDENCE-BASED PROOF TO EITHER SUPPORT OR REJECT THIS HYPOTHESIS. 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.

    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.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    A FACILITY REPORTED THAT DURAGEN (ID4501I) WAS IMPLANTED TO A PATIENT WITH MENINGIOMA. A MAGNETIC RESONANCE IMAGING (MRI) WAS PERFORMED THE DAY AFTER THE IMPLANTATION AND SHOWED NO ABNORMALITY. TWO DAYS AFTER THE IMPLANTATION, EPIDURAL HEMATOMA WAS OBSERVED. REOPERATION WAS PERFORMED AND THE HEMATOMA WAS REMOVED. IT WAS REPORTED THAT "THE DOCTOR ASSUMED THAT NOT BEING ABLE TO PLACE TENTING SUTURE MAY POSSIBLY BE THE CAUSE OF THE EVENT." THE EXACT IMPLANTATION DATE IS UNKNOWN, BUT IT WAS REPORTED THAT THE INCIDENT OCCURRED IN (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2149517 DURAGEN 4X5 1 PACK CE N/A GXQ INTEGRA - PRINCETON

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other