BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOVEIN

    MDR report key: 542129 · Received July 7, 2004

    Report

    Report Number
    542129
    Event Type
    Injury
    Date Received
    July 7, 2004
    Date of Event
    June 26, 2003
    Report Date
    July 6, 2004
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    LMO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    RECEIVED URGENT TISSUE NOTIFICATION FROM CRYOLIFE FOR A FEMORAL VEIN THAT HAD BEEN IMPLANTED INTO A PATIENT. THIS PROMPTED A RETROSPECTIVE REVIEW OF THE CASE, REVEALING THAT THE PATIENT DID HAVE POST-OP INFECTIONS REQUIRING SURGICAL INTERVENTION AND LONG-TERM ANTIBIOTICS. THE PATIENT UNDERWENT A RIGHT SUPERFICIAL FEMORAL VEIN TO SUPRARENAL INFERIOR VENA CAVA WITH CRYOPRESERVED FEMORAL VEIN, LEFT TO RIGHT SUPERFICIAL FEMORAL VEIN TO CRYOPRESERVED GRAFT, AND BILATERAL SUPERFICIAL FEMORAL ARTERY TO CRYOPRESERVED VEIN ARTERIOVENOUS FISTULA FOR VENOUS OBSTRUCTION (INFERIOR VENA CAVA, ILIAC, AND BILATERAL COMMON FEMORAL) WITH VENOUS CLAUDICATION. THE PATIENT DEVELOPED AN INFECTED LEFT GROIN HEMATOMA AND FEMORAL VENOUS BYPASS GRAFT DISRUPTION REQUIRING WIDE, SHARP DEBRIDEMENT AND JET LAVAGE OF BILATERAL GROINS, INTERPOSITION VEIN GRAFT TO FEM-FEM VENOUS BYPASS AND BILATERAL SARTORIUS FLAP COVERAGE OF FEMORAL VESSELS SEVERAL WEEKS LATER. OPERATIVE CLOSURE OF BOTH GROIN WOUNDS WAS DONE SEVERAL WEEKS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOVEIN FEMORAL VEIN ALLOGRAFT LMO CRYOLIFE, INC. V060 *
    2 CRYOVEIN FEMORAL VEIN ALLOGRAFT LMO CRYOLIFE, INC V060 *
    3 CRYOVEIN FEMORAL VEIN ALLOGRAFT LMO CRYOLIFE, INC V060 *
    4 CRYOVEIN FEMORAL VEIN ALLOGRAFT LMO CRYOLIFE, INC V060 *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R