BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLEY DOUBLE VELOUR VASCULAR GRAFT

    MDR report key: 84157 · Received April 14, 1997

    Report

    Report Number
    2242352-1997-00034
    Event Type
    Injury
    Date Received
    April 14, 1997
    Date of Event
    February 24, 1997
    Report Date
    March 18, 1997
    Manufacturer
    MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A RETURNED EXPLANTED SEGMENT OF THE GRAFT WAS EVALUATED BY OUR CONSULTING PATHOLOGIST. NOTE: SINCE THE DEVICE BATCH NUMBER IS NOT ATTAINABLE, A REVIEW OF THE BATCH RECORDS FOR THE DEVICE IS NOT POSSIBLE. GROSS DESCRIPTION: RECEIVED IN FORMALIN IS A SEGMENT OF DACRON VASCULAR GRAFT WHICH MEASURES UP TO 3.2CM IN DIAMETER BY APPROX. 2.2CM IN LENGTH. NO TISSUE IS IDENTIFIED ON THE OUTER SURFACE. NO PSEUDOINTIMA IS IDENTIFIED. REP. SECTIONS ARE EMBEDDED UNDER MD-953 AND MD-954. MICROSCOPIC DESCRIPTION: A WELL-HEALED DACRON VASCULAR GRAFT IS IDENTIFIED. A THIN PSEUDOINTIMA COMPOSED OF COLLAGEN AND A FEW FIBROBLASTS IS PRESENT ON THE LUMINAL SURFACE. FIBROBLASTS AND COLLAGEN ARE PRESENT WITHIN THE INTERSTICES OF THE VASCULAR GRAFT AND THE OUTER CAPSULE SHOWS A DENSE FIBROUS CAPSULE COMPOSED OF FIBROBLASTS AND COLLAGEN. NO THROMBOSIS IS IDENTIFIED. A MINIMAL FOREIGN BODY REACTION COMPOSED OF MACROPHAGES AND FOREIGN BODY GIANT CELLS IS PRESENT. THE VASCULAR GRAFT IS INTACT AND NO LOSS OF INTEGRITY IS NOTED. SUMMARY: IN INTACT DACRON VASCULAR GRAFT WITH NO LOSS OF INTEGRITY IS IDENTIFIED. A NORMAL HEALING RESPONSE HAS OCCURRED WITH PSEUDOINTIMA FORMATION ON THE LUMINAL SURFACE AND FIBROUS CAPSULE FORMATION ON THE OUTER SURFACE. NO THROMBOSIS IS PRESENT.

    Description of Event or Problem · 1

    THE GRAFT WAS IMPLANTED IN 1985 FOR AN ABDOMINAL AORTIC ANEURYSM REPAIR. IN 1988, THE PT HAD A PARTIAL GRAFT REPLACEMENT (UNK GRAFT) FOR A LEFT COMMON ILIAC ARTERY ANUERYSM, THAT WAS FOUND TO HAVE A PSEUDOANEURYSM AT THE SITE OF THE PROXIMAL ANASTOMOSIS. THE PSEUDOANEURYSM WAS RESECTED WITH A PIECE OF UNK GRAFT, ON 2/24/97. THE DR HAS STATED THAT THE PSEUDOANEURYSM IS NOT RELATED TO THE CONDITION OF THE INITIALLY IMPLANTED GRAFT. THE PT IS REPORTED TO BE DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOLEY DOUBLE VELOUR VASCULAR GRAFT Implant VASCULAR GRAFT DSY MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. 103168 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other