BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTEGRAFT COLLAGEN VASCULAR GRAFT

    MDR report key: 3040984 · Received January 25, 2007

    Report

    Report Number
    2247686-2006-00006
    Event Type
    Malfunction
    Date Received
    January 25, 2007
    Date of Event
    October 18, 2006
    Report Date
    January 22, 2007
    Manufacturer
    ARTEGRAFT, INC.
    Product Code
    LXA
    PMA / PMN Number
    N16837
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF RECENT COMPLAINT/MDR RECORDS DO NOT REFLECT SIGNIFICANT SIMILAR INCIDENTS OF VASCULAR GRAFT BLOCKAGE DUE TO INTIMAL HYPERPLASIA OR INTERVENTIONS DUE TO THAT DESCRIPTION. ARTEGRAFT QUALITY MANAGEMENT DOES REVIEW COMPLAINT TRENDING FOR SIMILAR TYPES OF PROBLEMS AND ISSUES ON A PERIODIC BASIS. THIS WILL CONTINUE PER STANDARD PROCEDURE. CA AS REQUIRED.

    Description of Event or Problem · 1

    CUSTOMER, DR. (B)(6), COMPLAINED OF LITTLE OR NO BLOOD FLOW FROM ARTERIAL VASCULAR GRAFT AFTER IMPLANTATION. BLOOD VESSEL, ARTERIO-VENOUS GRAFT, LEFT, REMOVAL. EXTENSIVE SUPPURATION AND NECROSIS OF LARGE MUSCULAR VESSEL. THERE ARE FOUR PORTIONS OF TAN FOCALLY RED, VASCULAR GRAFT WITH SMALL AMOUNT OF ATTACHED YELLOW GRAY NECROTIC APPEARING TISSUE WHICH RANGE FROM 4.7 X 1.0 CM TO 11.5 X 1.0 CM. THE LUMENS ARE FILLED WITH TAN NECROTIC APPEARING TISSUE. IT WAS REPLACED ONE DAY AFTER IMPLANTATION WITH ANOTHER GRAFT. IT IS BELIEVED THAT THE REPLACEMENT GRAFT WAS EPTFE. PHOENIX BAPTIST HOSPITAL. THE VASCULAR GRAFT IN QUESTION WAS RETURNED (IN SECTIONS) IN HOSPITAL PACKAGING FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTEGRAFT COLLAGEN VASCULAR GRAFT VASCULAR GRAFT LXA ARTEGRAFT, INC. AG740 06B028-006

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention