BEUDAMED
    FDA Adverse Event Death Summary report: N

    COSGROVE-EDWARDS ANNULOPLASTY SYSTEM WITH DURAFLO TREATMENT

    MDR report key: 1658848 · Received April 14, 2010

    Report

    Report Number
    2015691-2010-13113
    Event Type
    Death
    Date Received
    April 14, 2010
    Date of Event
    September 7, 2009
    Report Date
    March 18, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K980487
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. TWO REQUESTS WERE MADE (VIA E-MAIL) FOR THE DEVICE, OPERATIVE REPORT, AND ADDITIONAL INFORMATION; HOWEVER, NO RESPONSE WAS RECEIVED. THE DEVICE HISTORY RECORD (DHR) REVIEW HAS BEEN COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Description of Event or Problem · 1

    THE HOME PATIENT (HP) STATED THE BAG FELL AND THE SPIKE CAME OUT OF THE BAG. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) INSTRUCTED THE HOME PATIENT (HP) TO RECYCLE POWER TO CLEAR ALARM. THE HP STATED HE WOULD FINISH WITH MANUALS AND CALL THE NURSE (RN) REGARDING AIR DETECTION ALARM AND BEING CONNECTED. ON (B)(6) 2010 PRODUCT SURVEILLANCE SPOKE WITH THE HOME PATIENT'S ROOMMATE WHO STATED THE TABLE USED FOR BAGS DOES NOT HAVE AN EDGE AND THIS PARTICULAR NIGHT THE BAG WAS LIKELY NOT CENTERED. THERE HAVE BEEN NO OTHER INCIDENTS LIKE THIS AND EVERYTHING HAS BEEN FINE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS EXPIRED AFTER AN IMPLANT DURATION OF APPROXIMATELY 0.2 MONTHS, DUE TO UNKNOWN REASONS. IT IS UNKNOWN IF THE DEATH WAS DEVICE RELATED. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COSGROVE-EDWARDS ANNULOPLASTY SYSTEM WITH DURAFLO TREATMENT ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4625 R-08H1792

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death