BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMASHIELD MICROVEL DOUBLE VELOUR GRAFT

    MDR report key: 153421 · Received February 26, 1998

    Report

    Report Number
    6000072-1998-00005
    Event Type
    Injury
    Date Received
    February 26, 1998
    Date of Event
    January 26, 1998
    Report Date
    February 4, 1998
    Manufacturer
    MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
    Product Code
    MAL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A RETURNED SEGMENT OF THE EXPLANTED GRAFT WAS EVALUATED BY CO'S CONSULTING PATHOLOGIST. A COPY OF THAT REPORT IS ATTACHED. CODE: THE MFG BATCH RECORDS FOR THE DEVICE WERE REVIEWED. CODE: THE BATCH RECORDS ARE NOT ATYPICAL - THERE ARE NO SIMILAR INCIDENTS AGAINST THIS BATCH. RECEIVED IN FORMALIN A WRINKLED SEGMENT OF DACRON VASCULAR GRAFT WHICH MEASURES 8.0 X 5.0 X 2.0 CM. THE SPECIMEN HAS NOT BEEN FIXED APPROPRIATELY AND AUTOLYSIS IS PROMINENT GROSSLY. FOCAL AREAS OF FIBROUS TISSUE APPEAR TO BE PRESENT ON THE OUTER SURFACE. REPRESENTATIVE SECTION ARE EMBEDDED UNDER MD-999, MD-1000 AND MD-1002. THE SECTIONS SHOW THE PRESENCE OF A DACRON VASCULAR GRAFT WITH FOCAL LOSS OF INTEGRITY. FOCAL AREAS WITHIN THE TISSUE SECTIONS SHOW MINIMAL TO NO PRESENCE OF DACRON. THE DACRON VACULAR GRAFT IN THESE FOCAL AREAS HAS BEEN REPLACED BY A DENSE FIBROCONNECTIVE TISSUE. MARKED AUTOLYSIS IS PRESENT AND NO CELLULAR DETAIL CAN BE APPRECIATED. NONETHELESS, THE FIBROTIC HEALING RESPONSE IS PRESENT ON THE LUMINAL SURFACE OF THE GRAFT, WITHIN THE INTERSTICES OF THE GRAFT AND ON THE OUTER SURFACT OF THE GRAFT. THROMBOSIS IS NOT IDENTIFIED. A DACRON VASCULAR GRAFT WITH FOCAL LOSS OF INTEGRITY OF THE GRAFT IS IDENTIFIED. THESE FOCAL AREAS HAVE BEEN REPLACED BY A DENSE FIBROCONNECTIVE TISSUE. NO RUPTURE IS INDENTFIED. NO CELLULAR DETAIL CAN BE IDENTIFIED DUE TO AUTOLYSIS.

    Description of Event or Problem · 1

    THE GRAFT WAS IMPLANTED IN 1986. WHEN IT WAS EXPLANTED ON 1/26/1998, IT APPEARED TO BE EXHIBITING SOME LOSS OF INTEGRITY RELATIVE TO IT BECOMING "UNLACED". NOTE: THE MFR BELIEVES "UNLACED" TO MEAN DILATATION.

    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. 085168 204041

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other| R