BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS PERICARDIAL PATCH

    MDR report key: 1414963 · Received July 17, 2009

    Report

    Report Number
    2015691-2009-11094
    Event Type
    Death
    Date Received
    July 17, 2009
    Date of Event
    May 21, 2007
    Report Date
    June 9, 2009
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXZ
    PMA / PMN Number
    K833763
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. THE EVENT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. THROUGH FOLLOW UP WITH THE HEALTH CARE PROVIDER (VIA FAX), ADDITIONAL INFORMATION AND THE MORTALITY NOTE WAS RECEIVED. A DEVICE HISTORY RECORD REVIEW IS IN PROCESS. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) REVIEW WAS 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 IN 2007. ON 06/19/2009 (THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER), IT WAS LEARNED THAT THE CAUSE OF DEATH WAS DUE TO HEMODYANMIC INSTABILITY. PER THE MORTALITY NOTE: "BY AN APPROXIMATELY FOUR DAYS BEFORE THE PT'S DEATH, HER WBC COUNT HAD RISEN TO 50 AND SHE WAS STILL REQUIRING PHARMACOLOGICAL SUPPORT AND CVVHD. SHE WAS TAKEN BACK TO THE OR ON THAT DAY FOR A MEDIASTINAL EXPLORATION; IRRIGATION AND RECLOSURE WITH ESMARK BY DR. CORSO. AN ATTEMPT WAS MADE TO CLOSE THE CHEST, BUT HER HEMODYNAMICS WORSENED SO THE ESMARK CLOSURE WAS DONE. THERE WAS NO SIGN OF INFECTION BUT THE HEART WAS DILATED. SHE RETURNED TO ICU AND AT ABOUT 2 DAYS LATER, SHE BECAME MORE HYPOTENSIVE ON MAXIMUM SUPPORT. SHE EXPIRED IN THE NEXT DAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS PERICARDIAL PATCH PERICARDIAL PATCH DXZ EDWARDS LIFESCIENCES 4700 R-07C0592

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Death