BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCOL

    MDR report key: 532494 · Received July 2, 2004

    Report

    Report Number
    2031002-2004-00002
    Event Type
    Injury
    Date Received
    July 2, 2004
    Date of Event
    May 14, 2004
    Report Date
    June 4, 2004
    Manufacturer
    HANCOCK JAFFE LABORATORIES, INC.
    Product Code
    MDQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2004 A PROCOL BIOPROSTHESIS WAS IMPLANTED AS A FEMORAL-POPLITEAL BYPASS GRAFT IN THE LEG. THIS DEVICE IS APPROVED FOR AV ACCESS ONLY AND IS NOT APPROVED FOR ARTERIAL RECONSTRUCTION. HOWEVER, THE PT WAS VERY THIN WITH NO AVAILABLE NATIVE CONDUIT MATERIAL AND THE PHYSICIAN FELT THE PT HAD NO OTHER OPTIONS. THE PT PRESENTED AT THE E.R. WITH PAIN AND SWELLING OF THE LEG A MONTH LATER. UPON EXAM, BLEEDING WAS NOTED FROM A FOCAL AREA OF DISRUPTION LOCATED MID-GRAFT. THE GRAFT WAS LIGATED IN SITU AND ABANDONED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. ARTERIAL BYPASS EXPOSES THE GRAFT TO CONSTANT HIGHER PRESSURE THAN THE APPROVED INDICATION AND MAY HAVE BEEN A FACTOR IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROCOL BOVINE MESENTERIC VEIN BIOPROSTHESIS FOR VASCULAR ACCESS MDQ HANCOCK JAFFE LABORATORIES, INC. HJL016-40-N SB012042

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R