BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 1691755 · Received May 17, 2010

    Report

    Report Number
    2015691-2010-13355
    Event Type
    Death
    Date Received
    May 17, 2010
    Date of Event
    November 11, 2009
    Report Date
    April 16, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT RETURN THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. THE EVENT WAS LEARNED THROUGH VIA E-MAIL FROM DECEASED PATIENT'S HUSBAND. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. REQUESTS WERE MADE VIA E-MAIL FOR THE DEVICE, OPERATIVE REPORT, AND ADDITIONAL INFORMATION, HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED, DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY PATIENT¿S HUSBAND VIA INTERNET WEBSITES THAT, ¿ON (B) (6) 2009 I SUBMITTED AN INQUIRY; (B) (4). AT THE TIME OF THE SUBMISSION THE DOCTORS TOLD ME THE VALVE WAS GONE. THE VALVE HAD NOT DISAPPEARED BUT HAD FAILED OPEN. DR (B) (6) AT (B) (6) HAD THE VALVE THE FIRST PART OF (B) (6) WHEN HE REPLACED IT. I DO HAVE A PICTURE, CAN YOU EXPLAIN WHY IT FAILED. THANK YOU.¿ IPR DATA SHOWS DEVICE IS A 6900P, 31MM, (B) (4), IMPLANTED ON (B) (6) 2009 IN A TRICUSPID POSITION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. 04/19//10 E-MAIL FROM PATIENT'S HUSBAND WHICH STATED THAT HIS WIFE DIED ON (B) (6) 2010. PATIENT WAS HOSPITALIZED FOR 9 DAYS PRIOR TO HER DEATH. SHE WENT HOME 48 HOURS BEFORE HER DEATH. IT IS THE PATIENT'S HUSBAND'S IMPRESSION THAT THE VALVE LASTED ABOUT 60 DAYS BEFORE IT STARTED TO FAIL. PICTURE OF THE VALVE WAS PROVIDED BY PATIENT'S HUBAND. PATIENT'S HUSBAND WILL GIVE SURGEON AUTHORIZAION TO RELEASE ANY REPORTS OR ECHO. CD COPIES TO EDWARDS.

    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-09A0071

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death| H| L| S