BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING

    MDR report key: 2100909 · Received May 24, 2011

    Report

    Report Number
    2015691-2011-15599
    Event Type
    Death
    Date Received
    May 24, 2011
    Date of Event
    October 9, 2010
    Report Date
    April 25, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K083470
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: THE SURGEON'S RESPONSE PROVIDED THE CAUSE OF DEATH AS A VERY SEVERE INFECTION AND THE DATE OF DEATH WAS IDENTIFIED AS (B)(6) 2010. CONCLUSION: ALTHOUGH IT WAS NOT EXPRESSLY STATED, IT IS BELIEVED THIS PATIENT DIED FROM AN OVERWHELMING SYSTEMIC INFECTION. ENDOCARDITIS WAS NOT IMPLICATED AND ACCORDING TO THE HEALTH CARE PROVIDER, THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. CORRECTED DATA: THE DATE OF DEATH, DATE OF EVENT, IF EXPLANTED, IMPLANT DURATION, AGE OF DEVICE AT TIME OF EVENT AND LOCATION OF EVENT WERE ALL UPDATED BASED ON THE INFORMATION PROVIDED IN THE SURGEON'S RESPONSE.

    Additional Manufacturer Narrative · 1

    (B)(4) 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. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. DATE OF DEATH WAS NOT PROVIDED. CAUSE OF DEATH WAS NOT PROVIDED. LOCATION OF PATIENT AT TIME OF DEATH WAS NOT PROVIDED.

    Description of Event or Problem · 1

    EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR STERILIZED 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 HAS EXPIRED. THE DATE OF PATIENTS' DEATH AND IMPLANT DURATION ARE UNKNOWN. CAUSE OF DEATH HAS NOT BEEN PROVIDED; THEREFORE, IT IS UNKNOWN IF THE DEATH IS DEVICE RELATED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE SALES REP CALLED AND TALKED TO THE SURGEON WHO CONFIRMED "THAT THE EDWARDS'S DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEATH". THE DATE OF DEATH WAS GIVEN AS (B)(6) 2010 GIVING AN IMPLANT DURATION OF 37 DAYS OR 1 MONTH 7 DAYS. THE SURGEON INDICATED THE PATIENT HAD SEVERAL HEALTH PROBLEMS AT THE TIME (RESPIRATORY PROBLEMS AND HEART FAILURE) BUT HIS DEATH WAS CAUSED BY A VERY SEVERE INFECTION; HOWEVER, NO SOURCE OF THE INFECTION WAS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 5200 R-10C0473

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death