BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARDIAC

    MDR report key: 856298 · Received May 23, 2007

    Report

    Report Number
    MW5001961
    Event Type
    Death
    Date Received
    May 23, 2007
    Date of Event
    May 8, 2007
    Report Date
    May 23, 2007
    Manufacturer
    CARDICA, INC.
    Product Code
    FZP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INAPPROPRIATE AND OFF LABEL USE OF A MEDICAL DEVICE MANUFACTURED BY A COMPANY. THE DECEASED, UNKNOWINGLY WAS OPERATED ON BY A CARDIAC SURGEON WHO USED AN ANASTOMOTIC DEVICE, EITHER THE C-PORT SYSTEM OR THE PAS-PORT SYSTEM, DURING A CORONARY ARTERY BYPASS OPERATION. NOT ONLY WAS THERE NO CLINICAL INDICATION FOR USING THE DEVICE BUT IT WAS NOT DISCLOSED TO THE PATIENT OR THE FAMILY THAT THE CARDIAC SURGEON IN QUESTION RECEIVES FINANCIAL COMPENSATION FROM CARDICA FOR USING THE DEVICE. AS A CONSEQUENCE OF USING THE DEVICE THE PATIENT DIED ONE DAY AFTER BEING DISCHARGED FROM THE HOSPITAL. THE EXAMINER WHO HAS NOT ISSUED A REPORT AS OF YET, FOUND THAT THE BYPASS GRAFT DISLODGED FROM THE NATIVE CORONARY VESSEL AT THE SITE WHERE THE ANASTOMOTIC DEVICE WAS USED. THEREFORE, THE PATIENT DIED AS A CONSEQUENCE OF USING THE CARDICA ANASTOMOTIC DEVICE. THIS IS THE SECOND DEATH AT THIS INSTITUTION DIRECTLY ATTRIBUTABLE TO ONE OF THESE CARDICA DEVICES, THE FIRST ONE WAS NOT REPORTED TO THE FDA AS A DEVICE RELATED DEATH. THIS DEATH WAS SUPPRESSED BY THE COMPANY AND THE SURGEONS INVOLVED WITH THE CASE BECAUSE THE C-PORT DEVICE WAS ON THE BRINK OF BEING FDA APPROVED, WHICH IT SUBSEQUENTLY ACHIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIAC PAS-PORT/C-PORT FZP CARDICA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death