BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMASHIELD MICROVEL DOUBLE VELOUR GRAFT

    MDR report key: 96628 · Received June 5, 1997

    Report

    Report Number
    2242352-1997-00047
    Event Type
    Injury
    Date Received
    June 5, 1997
    Date of Event
    May 14, 1997
    Report Date
    May 14, 1997
    Manufacturer
    MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
    Product Code
    MAL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN UNIDENTIFIED SEGMENT OF GRAFT WAS RETURNED AND EVALUATED BY CO CONSULTING PATHOLOGIST. A COPY OF THAT RPT IS ATTACHED. ALTHOUGH THE EXACT BATCH NUMBER OF THE GRAFT THAT LEAKED IS UNK, THE MFG BATCH RECORDS FOR BOTH DEVICES WERE REVIEWED. THE BATCH RECORDS FOR BOTH BATCHES SHOWED NOTHING ATYPICAL. THERE ARE NO SIMILAR INCIDENTS AGAINST BATCH 296190. BATCH 056176 HAD ONE SIMILAR INCIDENT RPT'D, BUT FOR MINIMAL LEAKAGE. GROSS DESCRIPTION: RECEIVED IN FORMALIN IS A SEGMENT OF CRIMPED DACRON VASCULAR GRAFT MEASURING 38 CM IN LENGTH BY 1.1 CM IN OUTER DIAMETER. NO BLOOD OR TISSUE ELEMENTS ARE IDENTIFIED ON THE LUMINAL SURFACE OR THE PERIADVENTITIAL SURFACE. REP SECTIONS ARE EMBEDDED UNDER MD-959, MD-960 AND MD-961. MICROSCOPY DESCRIPTION: A COLLAGEN-COATED DACRON VASCULAR GRAFT WITH AN INTACT COLLAGEN IS IDENTIFIED. FOCAL AREAS OF BLOOD CELLS AND PROTEIN ARE IDENTIFIED FOCALLY ON THE LUMINAL AND PERIOADVERNTITIAL SURFACES.

    Description of Event or Problem · 1

    THE DR ANASTOMOSED TWO 8MM DIAMETER HEMASHIELD GRAFTS, END-TO-END, FOR A DEEP BILATERAL AXILLARY-BIFEMORAL BYPASS PROCEDURE. DURING THE PROCEDURE, ONE OF THE GRAFTS LEAKED APPROX TWO UNITS OF BLOOD THROUGH ITS WALLS. THE OTHER WAS BLOOD-TIGHT. THE DRS ELECTED TO ALLOW THE GRAFT TO LEAK FOR APPROX 45 MINUTES WITHOUT ATTEMPTING TO STOP THE LEAKAGE. EVENTUALLY, THE LEAKAGE BECAME LESS. THE GRAFT THAT LEAKED WAS EXPLANTED AND REPLACED WITH A GORETEX GRAFT. THE OTHER GRAFT WAS LEFT IN THE PT AND REANASTOMOSED TO THAT GORETEX GRAFT. THE PT WAS GIVEN TWO UNITS OF BLOOD. THE PT'S CONDITION IS REPORTED AS OK. NOTE: THE TWO HEMASHIELD GRAFTS USED IN THIS PROCEDURE WERE BOTH CATALAOG 095208, BATCH NUMBER 056176 AND BATCH NUMBER 296190. UNFORTUNATELY THE HOSP IS UNABLE TO IDENTIFY WHICH BATCH NUMBER WAS THE ONE THAT LEAKED AND WHICH BATCH NUMBER WAS LEFT IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMASHIELD MICROVEL DOUBLE VELOUR GRAFT Implant SEALED VASCULAR GRAFT MAL MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. 095208 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other| R