BEUDAMED
    FDA Adverse Event Death Summary report: N

    FEMORAL ACCESS DEVICE

    MDR report key: 2962547 · Received February 14, 2013

    Report

    Report Number
    3008500478-2013-00394
    Event Type
    Death
    Date Received
    February 14, 2013
    Date of Event
    January 29, 2013
    Report Date
    April 2, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    PMA / PMN Number
    K033464
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: THE CANNULA WAS VISUALLY INSPECTED AND NO VISUAL DEFECTS WERE FOUND ON THE CANNULA. THERE WAS NO KINK OBSERVED ON THE CANNULA. NO ROOT CAUSE COULD BE DETERMINED FOR THIS EVENT. THIS PRODUCT WAS USED OFF LABEL. EDWARDS DOES NOT HAVE DATA ABOUT HOW THE DEVICE ACTS AFTER IT HAS BEEN INSIDE A PATIENT FOR 5 DAYS. ADDITIONALLY THIS PRODUCT CODE DOES NOT BY DESIGN, CONTAIN A SUTURE RING. IT IS POSSIBLE THAT THE DEVICE COULD HAVE SLIPPED OUT OF THE INCISION WITHOUT A DEVICE DEFECT. THE CUSTOMER USED THE DEVICE OFF-LABEL. A MANUFACTURING DEFECT CANNOT BE CONFIRMED. INSTRUCTIONS FOR USE WERE REVIEWED AND IT STATES: EDWARDS LIFESCIENCES FEMORAL ACCESS CANNULAE ARE INTENDED FOR USE IN SITUATIONS WHICH REQUIRE RAPID FEMORAL VENOUS AND ARTERIAL ACCESS FOR SHORT-TERM (< 6 HOURS) CARDIOPULMONARY BYPASS. VESSEL ACCESS (VENOUS OR ARTERIAL) IS LEFT TO THE DISCRETION OF THE PHYSICIAN. SECURELY TIE-BAND THE CONNECTOR TO CANNULA JUNCTION PRIOR TO INITIATING BYPASS. WIRE REINFORCED CANNULAE SHOULD BE CLAMPED IN THE NON-REINFORCED SECTION LOCATED AT THE CONNECTOR END SINCE CLAMPING OF THE REINFORCED SECTION MAY PRODUCE PERMANENT CANNULA DEFORMATION, THEREBY IMPEDING FLOW THROUGH THE CANNULA AND RISKING PUNCTURE OR TEARING OF THE CANNULA. THIS DEVICE IS INTENDED FOR SHORT-TERM USE ONLY (< 6 HOURS). FOR CUT-DOWN PROCEDURES, DIRECTLY VISUALIZE VESSEL DURING INSERTION AND REMOVAL TO MINIMIZE VESSEL DAMAGE. MANUFACTURING RECORDS HAVE BEEN REVIEWED AND THERE ARE NO NONCONFORMANCES ASSOCIATED WITH THIS DEVICE. TRENDS WILL CONTINUE TO BE MONITORED ON A MONTHLY BASIS AND IF FURTHER ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION INTO ROOT CAUSE ANTICIPATED UPON PRODUCT RETURN FROM THE CUSTOMER. THIS DEVICE WAS USED OFF LABEL IN THE AORTA. THIS DEVICE DOES NOT HAVE A SUTURE BUMP THAT ALLOWS FOR SUTURING THE DEVICE IN PLACE TO PREVENT MOVEMENT OF THE CANNULA DURING POSITIONING. THIS DEVICE WAS IN PLACE FOR 1 WEEK PRIOR TO THE INJURY. THIS DEVICE IS ONLY INDICATED FOR USE FOR LESS THAN 6 HOURS.

    Description of Event or Problem · 1

    AS REPORTED, THE PATIENT SUFFERED FROM A SEVERE MITRAL VALVE ENDOCARDITIS. SHE WAS REANIMATED AND PUT ON ECMO SYSTEM ON (B)(6) 2013. ON (B)(6) 2013 SHE WAS OPERATED WITH OPEN MEDIAN STERNOTOMY (REPAIR OF THE MITRAL VALVE) AND AFTER THE CASE SHE WAS PUT ON ECMO. THE FEMII012AT FEMORAL VENOUS ACCESS CANNULA WAS USED FOR DIRECT ARTERIAL CANNULATION AND WAS PLACED IN THE AORTA. THE CHEST WAS CLOSED AND THE PATIENT WENT TO THE PEDIATRIC ICU. ON (B)(6) 2013 THE PATIENT HAD A STRONG BLEEDING AND HEMATOMA AND WAS BROUGHT IN THE O.R. UNDER EMERGENCY CONDITION WHERE THEY OPENED THE CHEST AND COULD SEE THAT THE CANNULA SLIPPED OUT OF THE AORTIC INCISION. THE PATIENT DIED IN THE O.R. THIS CANNULA WAS USED OFF LABEL IN THE AORTA. IT IS INTENDED FOR FEMORAL ACCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65336 FEMORAL ACCESS DEVICE CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF EDWARDS LIFESCIENCES FEMII012AT 58953259

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Death