BEUDAMED
    FDA Adverse Event Death Summary report: N

    FEMORAL VENOUS DRAINAGE CANNULA

    MDR report key: 85847 · Received April 18, 1997

    Report

    Report Number
    2953147-1997-00006
    Event Type
    Death
    Date Received
    April 18, 1997
    Date of Event
    February 22, 1997
    Report Date
    February 25, 1997
    Manufacturer
    D L P INC.
    Product Code
    DQR
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THERE WAS NO DEVICE FAILURE, MALFUNCTION OR COMPLAINT REPORTED. DURING PREPARATION FOR FEMORAL-FEMORAL CARDIOPULMONARY BYPASS, THE ATTENDING SURGEON MET RESISTANCE DURING ADVANCEMENT OF THE ENDOVENOUS DRAINAGE CANNULA. THE APPEARANCE OF THE CANNULA UNDER FLUOROSCOPY SUGGESTED A KINK. THE CANNULA AND GUIDEWIRE WERE WITHDRAWN AND THEN READVANCED UNEVENTFULLY INTO POSITION. A 2 VESSEL CABG WAS PERFORMED. DURING THE PROCEDURE THE VENOUS DRAINAGE FROM THE FEMORAL VEIN CANNULA DECREASED AND THE PT REQUIRED A BLOOD TRANSFUSION. AN ILIAC VEIN TEAR WAS SUSPECTED AND CONFIRMED AT LAPAROTOMY. EXPLORATION OF THE ABDOMEN WAS REPORTEDLY DIFFICULT DUE TO THE PT'S OBESITY. THE VEIN REPAIR WAS COMPLETED, BUT THE PT REMAINED HYPOTENSIVE. A STERNOTOMY WAS PERFORMED, AND A SUPPLEMENTAL VEIN GRAFT WAS ATTACHED TO THE RADIAL ARTERY GRAFT SUPPLYING THE LEFT ANTERIOR DESCENDING CORONARY ARTERY AS A BACK-UP (NO EVIDENCE FOR GRAFT FAILURE). SUBSEQUENTLY, THE PT REQUIRED A RIGHT VENTRICULAR ASSIST DEVICE, AND THEN AN INTRA-AORTIC BALLOON PUMP FOR BLOOD PRESSURE SUPPORT. THE PT REMAINED CRITICALLY ILL, AND DIED ON THE SECOND POSTOPERATIVE DAY WITH CARDIAC FAILURE AND RENAL INSUFFICIENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMORAL VENOUS DRAINAGE CANNULA CANNULA DQR D L P INC. EVDC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death