BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GELWEAVE

    MDR report key: 9985167 · Received April 22, 2020

    Report

    Report Number
    9612515-2020-00003
    Event Type
    Injury
    Date Received
    April 22, 2020
    Date of Event
    March 24, 2020
    Report Date
    April 30, 2020
    Manufacturer
    VASCUTEK LTD
    Product Code
    DSY
    UDI-DI
    05037881107639
    PMA / PMN Number
    K952293
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS NARRATIVE: SECTION H6 CONCLUSION CODE - 67 - NO PROBLEM FOUND - AS NO DEVICE OR DIAGNOSTIC SCAN DATA WAS RETURNED AND NO ISSUES FOUND WITH REGARDS TO THE ANALYSIS OF PRODUCTION RECORDS, NO ROOT CAUSE HAS BEEN DETERMINED. 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 DEVELOP, ACTION MAY BE TAKEN AT THAT TIME.

    Description of Event or Problem · 0

    ORIGINAL INFORMATION RECEIVED: ON THE 26-MAR-20 VASCUTEK LTD. RECEIVED THE FOLLOWING INFORMATION FROM OUR DISTRIBUTOR (TERUMO FRANCE): THE EVENT WAS REPORTED AS FOLLOWS: A PATIENT UNDERWENT AN AORTO BI-FEMORAL BYPASS PROCEDURE AND A GELWEAVE EXTRA LONG BIFURCATE DEVICE WAS USED. THE PATIENT SUFFERED IMMEDIATE THROMBOSIS. INTERVENTION WAS PERFORMED (UNKNOWN TYPE). THE PATIENT WAS LATER TRANSFERRED TO INTENSIVE CARE. ADDITIONAL INFORMATION RECEIVED: FOLLOWING THE PROCEDURE, AND DURING THE NIGHT THE PATIENT PRESENTED WITH AN INCOMPLETE ACUTE ISCHEMIA OF THE RIGHT LOWER LIMB. DOPPLER IMAGING CONFIRMED AN OCCLUSION IN THE RIGHT LEG. INTERVENTION PERFORMED. SURGICAL APPROACH MADE AT THE LEVEL OF THE RIGHT SCARPA. THE FOGARTY BRINGS BACK A SIGNIFICANT QUANTITY OF FRESH THROMBUS. ARTERIOGRAPHY SHOWS THROMBUS WITHIN THE BODY OF THE PROSTHESIS AND IN THE LEFT LEG. THE LAPAROTOMY IS REDONE AS WELL AS THE LEFT SCARPA. AORTIC CLAMPING, UPON OPENING OF THE AORTIC ANASTOMOSIS; THE BODY OF THE PROSTHESIS IS THE SEAT OF AN ADHERENT THROMBUS WHICH IS REMOVED WITH FORCEPS. FOGARTY COMPLEMENTARY IN THE 2 LEGS AND THE DEEP FEMORALS. CLOSURE OF THE SURGICAL ACCESS WAS COMPLETED. FAVORABLE EVOLUTION THEN AND DOPPLER CONTROL FINDING NO RESIDUAL THROMBUS AND A NORMAL PERMEABILITY OF THE PROSTHESIS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON THE (B)(6) 2020 VASCUTEK LTD. RECEIVED THE FOLLOWING INFORMATION FROM OUR DISTRIBUTOR ((B)(6): A PATIENT UNDERWENT AN AORTO BI-FEMORAL BYPASS PROCEDURE AND A GELWEAVE EXTRA LONG BIFURCATE DEVICE WAS USED. THE PATIENT SUFFERED IMMEDIATE THROMBOSIS. INTERVENTION WAS PERFORMED (UNKNOWN TYPE). THE PATIENT WAS LATER TRANSFERRED TO INTENSIVE CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450563 GELWEAVE GELWEAVE EXTRA LONG BIFURCATE DSY VASCUTEK LTD GELWEAVE 17851676 - 2384 05037881107639

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention