BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM

    MDR report key: 1408984 · Received July 3, 2009

    Report

    Report Number
    2015691-2009-10982
    Event Type
    Death
    Date Received
    July 3, 2009
    Date of Event
    April 25, 2009
    Report Date
    June 3, 2009
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K020864
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. THE EVENT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. THROUGH FOLLOW UP WITH THE SURGEON (VIA FAX), ADDITIONAL INFORMATION, THE OPERATIVE REPORT, AND THE DEATH SUMMARY WAS RECEIVED. A DEVICE HISTORY RECORD REVIEW IS IN PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS EXPIRED AFTER A IMPLANT DURATION OF APPROXIMATELY 0.07 MONTHS. PATIENT ALSO HAD A DEVICE EXPLANTED AND ANOTHER DEVICE IMPLANTED; PLEASE REFERENCE MEDWATCH REPORTS FILED. THE FOLLOWING WAS TAKEN EXACTLY FROM THE DEATH SUMMARY: ACIDOSIS PERSISTED, AND PATIENT HAD PHOSPHORUS OF 9 TO 11. HIS CPK (CREATINE PHOSPHOKINASE) WAS NOT ELEVATED AS MUCH AS YOU WOULD EXPECT FOR THAT DIAGNOSIS. THE INITIAL VALUES WERE 3,000 AND 5,000. HIS CARDIAC ENZYMES WERE NOT IMPRESSIVE, BUT HE DID REQUIRE INCREASING AMOUNTS OF SUPPORT, AS HE GOT SICKER. THROUGHOUT THE NEXT NIGHT HE HAD ACTIVE HEMODIALYSIS AND DEVELOPED PH OF 6.9 DESPITE EVERYTHING AND PASSED ON EARLY IN THE MORNING IN 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4900 R-08F1244

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death