BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GELWEAVE

    MDR report key: 10903463 · Received November 25, 2020

    Report

    Report Number
    9612515-2020-00016
    Event Type
    Malfunction
    Date Received
    November 25, 2020
    Date of Event
    October 28, 2020
    Report Date
    December 10, 2020
    Manufacturer
    VASCUTEK LTD
    Product Code
    DSY
    UDI-DI
    05037881106878
    PMA / PMN Number
    K952293
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H6: INVESTIGATION FINDINGS - 213 - NO DEVICE PROBLEM FOUND - NO ISSUE WAS FOUND WITH THE REVIEW OF BATCH MANUFACTURE OR TESTING PRIOR TO RELEASE. COONCLUSION - 4315 - CAUSE NOT ESTABLISHED - VASCUTEK LTD. HAD REQUESTED ADDITIONAL INFORMATION REGARDING THE USE/HANDLING OF THE DEVICE AND ANY PHOTOGRAPHY / VIDEO FILES OF THE PROCEDURE. THE CLINICIAN ADVISED THAT THE GRAFT WAS NOT UNDULY MISHANDLED, WAS NOT UNDER EXCESSIVE TENSION AND WAS SIZED CORRECTLY. THE REQUESTED VIDEO FOOTAGE HAS NOT BEEN PROVIDED TO AID THE INVESTIGATION DESPITE MULTIPLE REQUESTS. AS THE DEVICE WAS NOT AVAILABLE FOR TESTING AND THE RETAINED MANUFACTURING RECORDS CONFIRM THAT THE DEVICE/BATCH WAS MANUFACTURED TO SPECIFICATION; NO ROOT CAUSE CAN BE DETERMINED FOR THIS CASE. VASCUTEK LTD. NOW CONSIDERS THIS COMPLAINT CLOSED. FURTHER ACTION IS NOT PLANNED, HOWEVER, THE ISSUE WILL BE TRACKED AND TRENDED AS PART OF THE ON-GOING COMPLAINTS TRENDING AND REPORTING PROCESS AND IF AN ADVERSE TREND DEVELOPS ACTION MAY BE TAKEN AT THAT TIME.

    Description of Event or Problem · 0

    ON (B)(6) 2020 THE CLINICIAN HAD JUST IMPLANTED THE GELWEAVE GRAFT AND RELEASED THE CLAMP FORM THE AORTA, A SMALL 2MM TEAR WAS OBSERVED NEAR THE ANASTOMOSIS (2CM). THE TEAR WAS REPAIRED USING 5.0 PROLINE SUTURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE EVENT WAS REPORTED AS DEVICE RELATED AND POSSIBLY PROCEDURAL RELATED.

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION WAS PROVIDED. (B)(4). A 5-YEAR REVIEW OF SIMILAR COMPLAINTS WAS PERFORMED FOR ALL GELWEAVE DEVICES, A RATE OF (B)(4) WAS CONFIRMED. NO ADDITIONAL COMPLAINTS HAVE BEEN RECEIVED FROM DEVICES FROM SAME BATCH. ANALYSIS OF PRODUCTION RECORDS - A REVIEW OF QC AND MANUFACTURING RECORDS WAS PERFORMED WITH PARTICULAR ATTENTION TO POROSITY TESTING RESULTS. REVIEW SHOWED BATCH WAS MANUFACTURED TO DESIGN SPECIFICATION AND ALL POROSITY TESTING FELL WITHIN ACCEPTANCE CRITERIA. DEVICE NOT ACCESSIBLE FOR TESTING - DEVICE REMAINS IMPLANTED AND WAS NOT RETURNED FOR INVESTIGATION. VASCUTEK LTD. HAS REQUESTED ADDITIONAL INFORMATION AND IMAGES/VIDEO OF EVENT FROM THE SITE. NO DEVICE PROBLEM FOUND - NO ISSUE WAS FOUND WITH THE REVIEW OF BATCH MANUFACTURE OR TESTING PRIOR TO RELEASE. RESULTS PENDING COMPLETION OF INVESTIGATION. - VASCUTEK LTD. HAS REQUESTED FURTHER INFORMATION. CONCLUSION NOT YET AVAILABLE AS THE INVESTIGATION IS ON-GOING

    Description of Event or Problem · 1

    ON (B)(6) 2020 THE CLINICIAN HAD JUST IMPLANTED THE GELWEAVE GRAFT AND RELEASED THE CLAMP FORM THE AORTA, A SMALL 2MM TEAR WAS OBSERVED NEAR THE ANASTOMOSIS (2CM). THE TEAR WAS REPAIRED USING 5.0 PROLINE SUTURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE EVENT WAS REPORTED AS DEVICE RELATED AND POSSIBLY PROCEDURAL RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1368725 GELWEAVE GELWEAVE STRAIGHT DSY VASCUTEK LTD GELWEAVE STRAIGHT 17765618 05037881106878

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention