BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOGRAFT

    MDR report key: 204716 · Received December 31, 1998

    Report

    Report Number
    2183620-1998-00012
    Event Type
    Malfunction
    Date Received
    December 31, 1998
    Date of Event
    October 28, 1998
    Report Date
    December 30, 1998
    Manufacturer
    BIO-VASCULAR, INC.
    Product Code
    LXA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT ON 10/28/98, THE PT WAS BEING TREATED FOR SEVERE CLAUDICATION, FOOT ULCER. A FEMORO-CRURAL VEIN RECONSTRUCTION BYPASS PROCEDURE WAS PERFORMED UTILIZING THE BIOGRAFT. AFTER COMPLETING THE DISTAL VASCULAR SUTURE, THE BYPASS WAS PULLED UP TO ABOVE THE KNEE JOINT WHEN THE BYPASS SUDDENLY GAVE WAY AND IN THE MIDDLE THIRD OF THE GRAFT, A 4CM LONG LACERATION COULD BE PALPATED. AT THIS POINT THE BYPASS WAS INTERRUPTED AND IT BECAME OBVIOUS THAT THE LACERATION WAS SITUATED AT THE SUTURE LINE OF THE TWO GRAFTS. SEVERAL LONGITUDINAL TEARS COULD BE OBSERVED. THE SURGEON RESECTED THE LESIONED GRAFT AND REGRAFTED WITH ANOTHER BIOGRAFT DEVICE. A SECTION OF THE EXPLANTED BIOGRAFT WAS RETURNED TO BIO-VASCULAR, INC. FOR ANALYSIS. THE SECOND BIOGRAFT IMPLANT IS PATENT AND THE PT HAS EXPERIENCED NO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOGRAFT Implant UMBILICAL VEIN GRAFT LXA BIO-VASCULAR, INC. 407505 2-8B16-0220

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention