BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM

    MDR report key: 1844336 · Received September 24, 2010

    Report

    Report Number
    2015691-2010-14112
    Event Type
    Death
    Date Received
    September 24, 2010
    Date of Event
    June 10, 2010
    Report Date
    August 26, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K020864
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. THIS EVENT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. THE PATIENT ALSO HAD ANOTHER DEVICE IMPLANTED; (B)(4). THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER (VIA FAX), A COPY OF THE OPERATIVE REPORT WAS RECEIVED. THE DEVICE HISTORY RECORD (DHR) REVIEW HAS BEEN COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS EXPIRED. ON 09/02/2010 (THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER), A COPY OF THE OPERATIVE REPORT WAS RECEIVED. PER THE OPERATIVE REPORT OF (B)(6)2010, THE PATIENT HAD A MVR AND A TRICUSPID ANNULOPLASTY PERFORMED. "AFTER A LONG PERIOD OF REWARMING AND MAINTAINING ON BYPASS AND RESTING THE PATIENT, A SWAN-GANZ WAS PLACED , AND SHE WAS EVENTUALLY WEANED FROM BYPASS INITIALLY ON 5 MCG OF DOPAMINE. THIS WAS FOLLOWED BY HAVING TO PLACE HER ON AN EPINEPHRINE DRIP AS WELL AS OTHER MEDICATIONS WHICH ARE DOCUMENTED BY ANESTHESIA. THEY ACTUALLY WERE ABLE TO WEAN FROM BYPASS, AND LIMPED ALONG FOR AWHILE BEFORE THE PATIENT APPARENTLY COULD NOT SUSTAIN AN ADEQUATE CARDIAC OUTPUT AND CONTINUED TO HAVE RATHER FULMINANT FAILURE. AFTER A LONG PERIOD OF TRYING TO MAINTAIN CARDIAC OUTPUT IN THE OPERATING ROOM, DESPITE ALL MEASURES PHARMACOLOGICALLY AND MECHANICALLY, IT BECAME OBVIOUS THAT SHE WAS NOT GOING TO SURVIVE. SHE WAS BARELY MAINTAINING THE PRESSURE IN THE OPERATING ROOM, AND EVENTUALLY AFTER CLOSURE SHE ONLY HAD AN APPARENT BLOOD PRESSURE BY THE BALLOON PUMP, BUT WE CHOSE TO TAKE HER TO THE INTENSIVE CARE UNIT TO ALLOW THE FAMILY TO VISIT WITH HER, AND BASICALLY I THEN TOLD THAT SHE HAD NO CARDIAC OUTPUT AND THAT THE SITUATION WAS ENTIRELY ARTIFICIAL. SHE SUBSEQUENTLY WAS PRONOUNCED DEAD AT 12:55 P.M."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4900 R-07B0321

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death