BEUDAMED
    FDA Adverse Event Death Summary report: N

    GELWEAVE

    MDR report key: 1668151 · Received April 26, 2010

    Report

    Report Number
    9612515-2010-00001
    Event Type
    Death
    Date Received
    April 26, 2010
    Report Date
    April 26, 2010
    Manufacturer
    VASCUTEK LTD
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING AND QC RECORDS REVIEWED. RESULTS - THERE WERE A TOTAL OF 15 UNITS IN THE BATCH. THE QUALITY CONTROL AND MANUFACTURING RECORDS HAVE BEEN REVIEWED AND THERE IS NOTHING TO SUGGEST ANY PROBLEMS. ALL GRAFTS WERE GELATIN SEALED. AFTER SEALING, 100% OF ALL GRAFTS ARE LEAK TESTED. THE LEAK TEST RESULTS WERE WITHIN OUR SPECIFIED QUALITY CONTROL LIMITS FOR THIS PRODUCT. ALL GRAFTS WERE DISTRIBUTED IN OCTOBER 2007. THE USAGE RATE OF THIS PARTICULAR MODEL OF GRAFT IS SUCH THAT IT MAY BE ASSUMED THE MAJORITY HAVE NOW BEEN IMPLANTED. NO OTHER REPORTS HAVE BEEN RECEIVED FOR THE OTHER UNITS. CONCLUSIONS - THERE WAS AN ELEVEN DAY PERIOD BETWEEN GRAFT IMPLANTATION AND THE PATIENT'S DEMISE. IT CAN THEREFORE BE ASSUMED THAT THE IMPLANT PROCEDURE WAS COMPLETED AND GRAFT HAEMOSTASIS WAS ACHIEVED. IN THE ABSENCE OF ANY FURTHER INFORMATION, THE ROOT CAUSE OF THIS INCIDENT AND ANY CORRELATION WITH THE DEVICE PERFORMANCE CANNOT BE ESTABLISHED.

    Description of Event or Problem · 1

    THE EVENT OCCURRED AT RUSSIAN RESEARCH CENTRE OF SURGERY IN MOSCOW. THE GELWEAVE WAS USED TO TREAT A PATIENT WITH AN ANEURYSM OF THE ASCENDING AORTA AND ARCH. THE PATIENT HAD STENOSIS OF THE RIGHT CORONARY AND DIAGONAL ARTERY. THE GRAFT WAS IMPLANTED ON (B) (6) 2010. IT WAS REPORTED THAT THERE WAS A VERY LONG HAEMOSTASIS. POST OPERATION, THE PATIENT HAD ARRYTHMIA, AURICULAR FIBRILLATION, MULTIPLE ORGAN FAILURE, WITH ENCEPHALOPATHY, HYPERTHERMIA, HEPATO-RENAL FAILURE AND RESPIRATORY FAILURE. THE PATIENT DIED ON (B) (6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GELWEAVE VASCULAR PROSTHESIS DSY VASCUTEK LTD UNKNOWN 104081 1805

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death