BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMASHIELD WOVEN DOUBLE VELOUR GRAFT

    MDR report key: 154207 · Received March 4, 1998

    Report

    Report Number
    6000072-1998-00011
    Event Type
    Injury
    Date Received
    March 4, 1998
    Date of Event
    January 14, 1998
    Report Date
    February 9, 1998
    Manufacturer
    MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
    Product Code
    MAL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES OF THE PT'S BLOOD WERE EVALUATED BY CO CONSULTING PATHOLOGIST AS PER A SPECIAL REQUEST FROM THE DR. THE MFG BATCH RECORDS FOR THE DEVICE WERE REVIEWED. THE BATCH RECORDS WERE NOT ATYPICAL - THERE ARE NO SIMILAR INCIDENTS AGAINST THIS BATCH. CO RECEIVED 5 SAMPLES DATED 1/20, 1/30, 2/2, 2/6, AND 2/7, RESPECTIVELY. EACH SAMPLE WAS ANALYZED BY AN ELISA FOR ANTI-BOVINE AND ANTI-HUMAN TYPE I COLLAGEN ANTIBODIES. THE RESULTS ARE AS FOLLOWS: SAMPLE DATED 1/20, 1+ POSITIVE FOR BOVINE AND 1+ FOR HUMAN TYPE I COLLAGEN; SAMPLE DATED 1/30, 3+ POSITIVE FOR BOVINE AND 2+ FOR HUMAN TYPE I COLLAGEN; SAMPLE DATED 2/2, 2+ POSITIVE FOR BOVINE AND 1+ FOR HUMAN TYPE I COLLAGEN; SAMPLE DATED 2/6, 2+ POSITIVE FOR BOVINE AND 1+ FOR HUMAN TYPE I COLLAGEN; SAMPLE DATED 2/7, 2+ POSITIVE FOR BOVINE AND 1+ FOR HUMAN TYPE I COLLAGEN. FROM THESE DATA, IT WOULD APPEAR THAT THE ANTIBODY TITERS TO TYPE I COLLAGEN DID INCREASE TRANSIENTLY. IT IS NOT POSSIBLE TO DETERMINE WHETHER OR NOT THE PT'S FEVER WAS RELATED TO THESE ANTIBODIES SINCE THERE HAS NOT BEEN ANY SYSTEMATIC STUDIES PUBLISHED ON THE SUBJECT IN THE LITERATURE. ANTI-BOVINE OR HUMAN TYPE I COLLAGEN ANTIBODIES ARE ALSO FOUND IN SOME NORMAL HEALTHY SUBJECTS AS WELL.

    Description of Event or Problem · 1

    THE DR CLAIMS THAT THE GRAFT WAS IMPLANTED AS A THORACIC AORTIC REPLACEMENT GRAFT, AND ON POD#19 THROUGH POD#24, THE PT DEVELOPED A FEVER AS HIGH AS 39.2 DEGREES C OF UNKNOWN CAUSE. WBC AND CRP WERE NOT SIGNIFICANTLY ELEVATED. THE PT'S CONDITION IS REPORTED AS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMASHIELD WOVEN DOUBLE VELOUR GRAFT Implant SEALED VASCULAR GRAFT MAL MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. 175422 856169

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other