BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Gelweave¿

    MDR report key: 17223645 · Received June 29, 2023

    Report

    Report Number
    9612515-2023-00006
    Event Type
    Injury
    Date Received
    June 29, 2023
    Date of Event
    July 27, 2021
    Report Date
    June 29, 2023
    Manufacturer
    VASCUTEK LTD
    Product Code
    DSY
    UDI-DI
    05037881107639
    PMA / PMN Number
    K964665
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS NARRATIVE SECTION H6 HEALTH EFFECT - CLINICAL CODE: 4580 - INSUFFICIENT INFORMATION - GELWEAVE BIFURCATE GRAFT WAS IMPLANTED TO TREAT AORTO-FEMORAL ANEURYSM. SHORTLY AFTER PROCEDURE POST-OPERATIVE ACUTE ISCHEMIA DUE TO EARLY OCCLUSION OF GELWEAVE DEVICE IDENTIFIED. HEALTH IMPACT - IMPACT CODE: 4625 - ADDITIONAL SURGERY- TO RESOLVE THE EVENT MEDICATION (UNKNOWN TYPE) WAS GIVEN TO THE PATIENT. THROMBUS WAS REMOVED FROM THE DEVICE. 12X38MM BENTLEY STENT WAS IMPLANTED IN ADRENAL AORTA ABOVE GELWEAVE GRAFT TO AVOID STENOSIS OF ANASTOMOTIC SITE. MEDICAL DEVICE PROBLEM CODE: 2423 - OBSTRUCTION OF FLOW - THROMBUS WAS REMOVED FROM THE DEVICE. 12X38MM BENTLEY STENT WAS IMPLANTED IN ADRENAL AORTA ABOVE GELWEAVE GRAFT TO AVOID STENOSIS OF ANASTOMOTIC SITE. COMPONENT CODE: 4755 - PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE - THE DEVICE DOES NOT HAVE DISTINCT PARTS, COMPONENTS, OR SUBASSEMBLIES. TYPE OF INVESTIGATION: 4110 - TREND ANALYSIS. A SIMILAR EVENT REVIEW WAS PERFORMED FOR OCCLUSIONS IN GELWEAVE GRAFTS BETWEEN JAN 19 AND JUN 23. A SIMILAR EVENT RATE OF 0.006% WAS CONFIRMED. NO NEGATIVE TREND IN THE NUMBER OF EVENTS WAS IDENTIFIED. 4111 - COMMUNICATION/INTERVIEWS - FURTHER INFORMATION HAS BEEN REQUESTED FROM THE SITE. 3331- ANALYSIS OF PRODUCTION RECORDS - A REVIEW OF MANUFACTURING AND QUALITY CONTROL RECORDS CONFIRMED THAT THE DEVICE WAS MANUFACTURED TO THE INTENDED SPECIFICATIONS. INVESTIGATION FINDINGS: 213 - NO DEVICE PROBLEM FOUND - NO ISSUE HAS BEEN FOUND UPON REVIEW OF THE RETAINED DEVICE HISTORY RECORDS. COMPLAINANT ASLO CONFIRMED THAT THE DEVICE WAS NOT KINKED OR TWISTED, ALSO THE PATIENT DID NOT HAVE ANY ALLERGIES TO THE GRAFTS COMPONENTS. INVESTIGATION CONCLUSION: 4315 - CAUSE NOT ESTABLISHED- DEVICE SHOWED OCCLUSION APPROXIMATELY 3 HOURS AFTER PROCEDURE. A THROMBECTOMY WAS CARRIED OUT AND THE GRAFT REMAINED PATENT AFTERWARDS. PATIENT RECOVERED, EVENT RESOLVED WITHOUT SEQUELAE.

    Description of Event or Problem · 0

    HIS EVENT WAS REPORTED TO VASCUTEK LTD VIA THE PANTHER STUDY PROGRAMME AS FOLLOWS: ON (B)(6) 2021 A GELWEAVE BIFURCATE GRAFT WAS IMPLANTED TO TREAT AORTO-FEMORAL ANEURYSM. SHORTLY AFTER PROCEDURE POST-OPERATIVE ACUTE ISCHEMIA DUE TO EARLY OCCLUSION OF GELWEAVE DEVICE IDENTIFIED. TO RESOLVE THE EVENT MEDICATION (UNKNOWN TYPE) WAS GIVEN TO THE PATIENT. THROMBUS WAS REMOVED FROM THE DEVICE. 12X38MM BENTLEY STENT WAS IMPLANTED IN ADRENAL AORTA ABOVE GELWEAVE GRAFT TO AVOID STENOSIS OF ANASTOMOTIC SITE. PATIENT RECOVERED WITHOUT SEQUELAE. THE SITE HAS INDICATED THAT THIS EVENT IS POSSIBLY RELATED TO THE PROCEDURE, DEVICE AND PATIENT PRE-EXISTING CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1321188 Gelweave¿ GELWEAVE BIFURCATE DSY VASCUTEK LTD 731608XL55 21540854 05037881107639

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention