BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING

    MDR report key: 1654846 · Received April 9, 2010

    Report

    Report Number
    2015691-2010-13090
    Event Type
    Death
    Date Received
    April 9, 2010
    Date of Event
    February 13, 2010
    Report Date
    March 12, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K912554
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: MODERATE TO HEAVY HOST TISSUE OVERGROWTH IS EVIDENT AT BOTH ASPECTS OF THE RING. MINOR CUT ARE DETECTED IN THE SEWING RING FABRIC. NO OTHER INCONSISTENCIES DETECTED OR IN THE X-RAY. X-RAYADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE EVALUATION WAS COMPLETED ON 05/25/2010.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. THE 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), ADDITIONAL INFORMATION AND THE OPERATIVE REPORT WAS RECEIVED. 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

    THE LAST FILL (LF) =1500 ML AND NOT 15000 ML AS PREVIOUSLY REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS EXPIRED AFTER AN IMPLANT DURATION OF APPROXIMATELY 0.1 MONTHS. ON (B) (6) 2010 (THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER), IT WAS LEARNED THAT CAUSE OF DEATH WAS PNEUMONIA. PER THE OPERATIVE REPORT OF (B) (6) 2010, "THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO THE INTENSIVE CARE UNIT IN SATISFACTORY CONDITION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4500 R-09F1417

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death