BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOGRAFT

    MDR report key: 153277 · Received February 27, 1998

    Report

    Report Number
    2183620-1998-00005
    Event Type
    Injury
    Date Received
    February 27, 1998
    Date of Event
    December 12, 1997
    Report Date
    February 26, 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

    Additional Manufacturer Narrative · 1

    CO RECEIVED THE EXPLANTED SAMPLE GRAFT ON 4-20-98. CO PERFORMED AN INITIAL EXAMINATION AT BIO-VASCULAR, INC. THE EXAMINATION SHOWED NOTHING UNUSUAL IN APPEARANCE, THICKNESS OR STRUCTURE OF THE SAMPLE GRAFT. SPECIMENS WERE SENT OUT FOR HISTOLOGY STAINING AND SLIDE PREPARATION ON 4-27-98. AFTER CO RECEIVED THE HISTOLOGY SLIDES, CO CONSULTED A CARDIOVASCULAR SURGEON WITH EXPERTISE IN IMPLANTATION OF VASCULAR GRAFTS. DR OFFERED CO HIS SERVICES AND THOSE OF THE HISTOPATHOLOGISTS AT HIS FACILITY. CO THEN SHIPPED THE HISTOLOGY SLIDES TO DR.'S FACILITY FOR EVALUATION. DR CONTACTED CO WITH HIS COMPLETE HISTOLOGY FINDINGS ON 6-11-98. DR STATED THAT THE TISSUE STRUCTURE WAS VERY NORMAL IN CHARACTER AND THAT THEY WERE UNABLE TO IDENTIFY ANY WEAK AREAS OR EVIDENCE OF DEGENERATION.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT ON 06/03/1997, THE PT WAS TREATED FOR CRITICAL ISCHEMIA BY A FEMORAL BYPASS PROCEDURE USING A BIOGRAFT DEVICE. THE SURGEON CLAIMS THAT ON 12/12/1997 DIFFUSE DEGENERATION OF THE GRAFT WAS DISCOVERED WITHIN THE DISTAL THIRD OF THE GRAFT. NOTE THAT THE DEGENERATION WAS NOT APPARENT UNTIL 6 MOS POST-IMPLANT. AT THIS TIME, THE SURGEON PERFORMED A THROMBECTOMY OF THE GRAFT. THE PT IS CURRENTLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOGRAFT Implant UMBILICAL VEIN GRAFT LXA BIO-VASCULAR, INC. 406505 1-6E28-0761

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention