BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PHSIO ANNULOPLASTY RING

    MDR report key: 1671325 · Received May 1, 2010

    Report

    Report Number
    2015691-2010-13255
    Event Type
    Death
    Date Received
    May 1, 2010
    Date of Event
    March 3, 2010
    Report Date
    April 1, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K926138
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. THE INFORMATION WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, A COPY OF THE OPERATIVE REPORT WAS RECEIVED. THE CAUSE OF DEATH REMAINS UNKNOWN. 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. NO FURTHER DETAILS WERE PROVIDED. THE DATE OF PATIENT'S DEATH AND IMPLANT DURATION ARE UNKNOWN. IT IS UNKNOWN IF THE DEATH WAS DEVICE RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS EXPIRED AFTER AN IMPLANT DURATION OF APPROXIMATELY 0.03 MONTHS, DUE TO UNKNOWN REASONS. NO FURTHER DETAILS WERE PROVIDED. 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 WAS MADE READY FOR TRANSPORT TO RECOVERY WITH GUARDED CONCERNS WITH ONGOING INOTROPIC SUPPORT WITH INTRAAORTIC BALLOON COUNTERPULSATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PHSIO ANNULOPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4450 R-09K2330

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death