BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING

    MDR report key: 2001491 · Received February 25, 2011

    Report

    Report Number
    2015691-2011-14900
    Event Type
    Death
    Date Received
    February 25, 2011
    Date of Event
    July 15, 2010
    Report Date
    January 28, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K926138
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. ON (B)(6) 2011, A RESPONSE WAS RECEIVED FROM THE HEALTH CARE PROVIDER WHICH INDICATED THAT THE DATE OF DEATH WAS (B)(6) 2010. THE CAUSE OF DEATH WAS PROVIDED AS "CARDIOGENIC SHOCK, SUDDEN DEATH." NO AUTOPSY OR CERTIFICATE OF DEATH WAS PROVIDED AND IT WAS INDICATED THAT THE DEVICE REMAINS IMPLANTED -- WILL NOT BE RETURNED FOR EVALUATION. THE OPERATIVE REPORT WAS PROVIDED, BUT IS NOT IN ENGLISH.

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: DESPITE OUR ATTEMPTS TO RECEIVE FURTHER INFORMATION REGARDING THE DEVICE AND EVENT, NO RESPONSE OR SAMPLE FOR EVALUATION WAS RECEIVED FROM THE HEALTH-CARE PROVIDER. CAUSE OF DEATH HAS NOT BEEN PROVIDED. IT IS UNKNOWN IF THE DEVICE WAS EXPLANTED OR IF AN AUTOPSY WAS DONE. A DEVICE HISTORY RECORD REVIEW IS IN PROGRESS.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A RESPONSE WAS RECEIVED FROM THE SURGEON WHICH CONFIRMED THE DATE OF DEATH AS (B)(6) 2010. THE IMPLANT DURATION OF WAS 3 DAYS (0.10 MONTHS). CAUSE OF DEATH WAS PROVIDED WAS CARDIOGENIC SHOCK, SUDDEN DEATH.

    Description of Event or Problem · 1

    EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT". THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE. IN THIS CASE, THE PATIENT EXPIRED. THE DATE OF PATIENTS' DEATH AND IMPLANT DURATION ARE UNKNOWN. CAUSE OF DEATH HAS NOT BEEN PROVIDED. IT IS UNKNOWN IF THE DEATH WAS DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4450 10C076

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death