BEUDAMED
    FDA Adverse Event Other Summary report: N

    GELWEAVE 4 BRANCH

    MDR report key: 851320 · Received May 11, 2007

    Report

    Report Number
    9612515-2007-00001
    Event Type
    Other
    Date Received
    May 11, 2007
    Date of Event
    December 27, 2006
    Report Date
    May 8, 2007
    Manufacturer
    VASCUTEK LTD.
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    A) REVIEW OF RECORDS: THE QC AND BATCH MFG RECORDS WERE REVIEWED AND SHOWED NO ABNORMALITIES. RESULTS BATCH REPORT: THERE WERE THREE GRAFTS IN THE BATCH, THESE WERE DISTRIBUTED BETWEEN JULY AND AUGUST 2006 AND TO OUR KNOWLEDGE ALL OTHER GRAFTS HAVE BEEN IMPLANTED WITHOUT INCIDENT. B) MANUFACTURERS COMMENTS: THE CAUSE OF ALL THREE LEAKAGES ARE UNKNOWN. THE GRAFT IS SEALED WITH GELATIN. WHEN IMPLANTED, THE GELATIN ACTS AS A SEALANT. OVER A 14-DAY PERIOD, THE GELATIN DEGRADES AND IS SUBSTITUTED WITH TISSUE IN-GROWTH. WHEN THE OPERATION WAS COMPLETED, WE CAN ONLY ASSUME THERE WAS NO LEAKAGE AND THE SURGEON FINISHED THE OPERATION. VASCUTEK IS UNABLE TO OFFER ANY EXPLANATION FOR THE EVENTS IMMEDIATELY AFTER THE OPERATION AND A FEW DAYS LATER. FOR THE EVENT WHICH OCCURRED APPROXIMATELY THREE MONTHS LATER, VASCUTEK WOULD EXPECT THE GELATIN TO HAVE DEGRADED AND TISSUE IN-GROWTH TO HAVE SEALED THE GRAFT. CONCLUSIONS - NO CONCLUSIONS CAN BE DRAWN.

    Description of Event or Problem · 1

    THE INCIDENT OCCURRED IN HOSPITAL IN ANOTHER COUNTRY. A GELWEAVE VASCULAR PROSTHESIS WAS IMPLANTED TO AVERT A DISSECTION OF THE AORTA IN A FEMALE. THE DOCTOR CARRIED OUT 3 INTERVENTIONS OVER A 3 MONTH PERIOD AFTER GRAFT IMPLANTATION. AFTER THE OPERATION IN 2006, THE DOCTOR FOUND A DECREASE IN BLOOD PRESSURE, HE REOPENED THE CHEST AND FOUND BLEEDING ON THE GRAFT FROM THE ROOT OF ONE OF THE BRANCHES. A FEW DAYS LATER, THE DOCTOR FOUND A DECREASE IN BLOOD PRESSURE AGAIN, A CT SCAN WAS PERFORMED AND MORE BLEEDING WAS FOUND, THE CHEST WAS REOPENED AND A PIN HOLE WAS FOUND ON THE GRAFT. IN 2007, A DECREASE IN BLOOD PRESSURE WAS FOUND, THE DOCTOR CONFIRMED BLEEDING FROM LOWER PART OF BRACHIOCEPHALIC ARTERY. THE GRAFT REMAINS IMPLANTED AND TO OUR KNOWLEDGE, THE PATIENT HAS SUFFERED NO LONG TERM ILL EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GELWEAVE 4 BRANCH VASCULAR PROSTHESIS DSY VASCUTEK LTD. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention