BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 1654842 · Received April 9, 2010

    Report

    Report Number
    2015691-2010-13089
    Event Type
    Death
    Date Received
    April 9, 2010
    Date of Event
    February 13, 2010
    Report Date
    March 12, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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) (6). 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.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: A DIAGONAL CUT, ACROSS THE CUSP AREA OF LEAFLET 3, MEASURES TO APPROXIMATELY 12MM. MULTIPLE TEARS/CUT IN THE TISSUE OF LEAFLET 2, AT THE FREE MARGIN AND THE CUSP AREA, MEASURES TO APPROXIMATELY 12MM; THE TEARS ARE MOST LIKELY DUE TO MECHANICAL DAMAGE. THE WIREFORM IS EXPOSED AT COMMISURE 3 DUE TO CUTS IN THE SEWING FABRIC. ALSO AT COMMISSURE 3, WIREFORM TO BAND SEPARATION IS NOTED IN THE X-RAY. MODERATE HOST TISSUE IS DETECTED AT THE STENT INFLOW AND THE STENT OUTFLOW. NO OTHER INCONSISTENCIES DETECTED. X-RAY. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE EVALUATION WAS COMPLETED ON 05/27/2010.

    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."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 121.6 MONTHS, DUE TO UNKNOWN REASONS. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900P R-08C0522

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death