BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMASHIELD MICROVEL DOUBLE VELOUR GRAFT

    MDR report key: 50859 · Received September 24, 1996

    Report

    Report Number
    2242352-1996-00013
    Event Type
    Malfunction
    Date Received
    September 24, 1996
    Date of Event
    August 29, 1996
    Report Date
    August 29, 1996
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MAL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN UNIMPLANTED SEGMENT OF THE COMPLAINT GRAFT WAS EVALUATED BY CO'S CONSULTING PATHOLOGIST. RECEIVED IN FIXATIVE IS A SEGMENT OF UNIMPLANTED VASCULAR GRAFT. THE SPECIMENT MEASURES 3.2 CM IN LENGTH BY 2.4 CM IN DIAMETER. THE SURFACES ARE CLEAN. REPRESENTATIVE SECTIONS ARE EMBEDDED. A COLLAGEN-COATED VASCULAR GRAFT IS IDENTIFIED. COLLAGEN IS PRESENT ON THE LUMINAL SURFACE, ADVENTITIAL SURFACE AND WITHIN THE INTERSTICES OF THE VASCULAR GRAFT. NO LOSS OF INTEGRITY OF THE COLLAGEN COATING IS IDENTIFIED. NO LOSS OF INTEGRITY OF THE VASCULAR GRAFT IS IDENTIFIED. AN INTACT COLLAGEN-COATED VASCULAR GRAFT IS IDENTIFIED WITH NO LOSS OF INTEGRITY OF THE COLLAGEN COATING.

    Description of Event or Problem · 1

    THE GRAFT, WHICH WAS IMPLANTED FOR AN AORTIC ANEURYSM, LEAKED APPROX. 400CC OF BLOOD THROUGH ITS WALLS WHEN THE CLAMP WAS RELEASED. A TRANSFUSION SET WAS USED, SO THE BLOOD WAS RETURNED TO THE PT. THE MD REPEATEDLY CLOSED AND OPENED THE CLAMP UNTIL HEMOSTASIS WAS ATTAINED. AT THIS TIME, THE PT IS STILL IN SURGERY. THE PT'S CONDITION IS REPORTED AS FINE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMASHIELD MICROVEL DOUBLE VELOUR GRAFT Implant SEALED VASCULAR GRAFT MAL BOSTON SCIENTIFIC CORPORATION 085201 026153

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other| R