BEUDAMED
    FDA Adverse Event Other Summary report: N

    GELWEAVE ANTE-FLO

    MDR report key: 1546771 · Received November 26, 2009

    Report

    Report Number
    9612515-2009-00011
    Event Type
    Other
    Date Received
    November 26, 2009
    Date of Event
    October 9, 2009
    Report Date
    November 27, 2009
    Manufacturer
    VASCUTEK LTD.
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - MANUFACTURING AND QC RECORDS TO BE REVIEWED. RESULTS - THE MANUFACTURING AND QC RECORDS HAVE BEEN REVIEWED. THERE WERE A TOTAL OF 7 GRAFTS PRODUCED IN THE BATCH. THEY WERE ALL DISTRIBUTED BETWEEN APRIL AND JUNE 2009. ALL THE GRAFTS PASSED THE 100% POROSITY TEST. THERE WAS NOTHING TO SUGGEST ANY PROBLEMS WITH THE BATCH. THE USAGE RATE IS SUCH THAT IT IS EXPECTED THE MAJORITY OF GRAFTS HAVE BEEN IMPLANTED. THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS BATCH OF VASCULAR PROSTHESES. VASCUTEK ARE AWARE OF PREVIOUS OCCURRENCES WHERE REINTERVENTION HAS BEEN REQUIRED TO STEM BLOOD FLOW. (B)(4). IT IS NOT KNOWN WHAT CAUSED THE LEAKAGE ON THIS OCCASION. CLINICAL TRIAL DATA: LEAKAGE IS A KNOWN AND EXPECTED COMPLICATION OF VASCULAR GRAFT IMPLANTATION. THE ORIGINAL VASCUTEK CLINICAL TRIAL FOR GELATIN SEALED DEVICES HAD A LEAK INCIDENCE OF 2.5%. THE CURRENT INCIDENCE FOR GELATIN SEALED GRAFTS IS LESS THAN 0.04%. CONCLUSIONS - VASCUTEK WILL RESPOND TO THE SURGEON AND PROVIDE DETAILS OF THE RESPONSE IN OUR FINAL REPORT.

    Description of Event or Problem · 1

    THE EVENT OCCURRED AT (B)(6) HOSPITAL. THE EVENT IS BEING REPORTED AS INTERVENTION WAS REQUIRED TO STOP BLEEDING FROM A GELWEAVE VASCULAR PROSTHESIS. THE PATIENT UNDERWENT AN AORTA REPLACEMENT PROCEDURE USING A GELWEAVE ANTE-FLO SINGLE BRANCH GRAFT ON THE (B)(6) 2009. ON (B)(6) 2009, THE DOCTOR OPENED THE CHEST AGAIN AND STOPPED BLEEDING USING TACOCOMB. FEVER WAS REPORTED, BUT NO BACTERIAL INFECTION WAS IDENTIFIED IN ANY OF THE BLOOD THAT HAD BEEN DRAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GELWEAVE ANTE-FLO VASCULAR PROSTHESIS DSY VASCUTEK LTD. UNK 99940 1470

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention