BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING

    MDR report key: 1874295 · Received October 19, 2010

    Report

    Report Number
    2015691-2010-14219
    Event Type
    Death
    Date Received
    October 19, 2010
    Date of Event
    July 3, 2010
    Report Date
    September 22, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K912554
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: ON (B)(6) 2010, WE RECEIVED THE OPERATIVE REPORT AND DISCHARGE SUMMARY. PRE-OP DIAGNOSES INCLUDES BACTERIAL ENDOCARDITIS, AORTIC VALVE DYSFUNCTION, TRICUSPID REGURGITATION, DOUBLE VESSEL DISEASE, AND AF. FOR THE EDWARDS LIFESCIENCES DEVICE, THE PRE-OPERATIVE DIAGNOSIS WAS TRICUSPID REGURGITATION. THE RING WAS SUCCESSFULLY REPLACED WITH SAME MODEL, SMALLER SIZE DEVICE. NO INDICATION WAS GIVEN THAT THERE WAS ANY ISSUE WITH THIS DEVICE. THE OPERATIVE REPORT CITES AORTIC VALVE REPLACEMENT DUE TO PROSTHETIC VALVE DYSFUNCTION - PROSTHETIC VALVE ENDOCARDITIS. IT WAS ALSO LEARNED THAT THE PATIENT HAD EXPIRED POST-OPERATIVELY. IN A PHONE CALL TO THE SURGEON'S OFFICE ON (B)(6) 2010, CAUSE OF DEATH WAS PROVIDED AS FATAL HEART FAILURE. AT THE TIME OF DEATH, THE PATIENT ALSO HAD A MITROFLOW 25MM VALVE IMPLANTED IN THE AORTIC POSITION. SURGEON'S OFFICE PROVIDED THE DISCHARGE SUMMARY WHICH PROVIDED THE FOLLOWING INFORMATION: HEART WAS SUCCESSFULLY RECONSTRUCTED. UNFORTUNATELY, RIGHT VENTRICULAR FAILURE ENSUED DUE TO PULMONARY HYPERTENSION. KIDNEY AND LIVER FAILED. UNABLE TO SUPPORT BLOOD PRESSURE DESPITE HIGH DOSE OF ALL PRESSORS. THERE IS NO EVIDENCE THAT THE PATIENT'S DEATH WAS RELATED TO THE EDWARDS LIFESCIENCES ANNULOPLASTY RING.

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. CUSTOMER LETTER NOT REQUESTED. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. IT IS UNKNOWN IF THE DEVICE WAS EXPLANTED OR IF AN AUTOPSY WAS DONE. THEREFORE, IT IS ASSUMED THAT THERE IS NO DEVICE RETURN FOR EVALUATION. THERE HAVE BEEN NO RESPONSES TO OUR REPEATED ATTEMPTS ON 09/24/2010, 10/02/2010 AND ON 10/18/210 TO CONTACT THE HEALTH CARE PROVIDER REGARDING THE DETAILS OF THE EVENT AND PRODUCT RETURN. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED AFTER AN IMPLANT DURATION OF APPROXIMATELY 0.07 MONTHS DUE TO UNKNOWN REASONS. IT IS UNKNOWN IF THE DEATH WAS DEVICE RELATED. NO FURTHER DETAILS WERE PROVIDED. INFORMATION LEARNED FROM OUR IMPLANT PATIENT REGISTRY. PATIENT HAD ANOTHER DEVICE EXPLANTED AT THE TIME THIS DEVICE WAS IMPLANTED. (B)(4)

    Description of Event or Problem · 1

    AN EVENT WAS RECEIVED THROUGH THE EDWARDS LIFESCIENCES IMPLANT PATIENT REGISTRY. THIS "REGISTRY" IS A PATIENT TRACKING MECHANISM FOR SERIALIZED DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET REGISTRY. PATIENT AND DEVICE STATUS ARE REPORTED THROUGH THE REGISTRY. THIS INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED BY EDWARDS AS A CONVENTIONAL CUSTOMER COMPLAINT. ACCORDING TO THE DISCHARGE SUMMARY, THE PATIENT EXPIRED 1 DAY POST-OP DUE TO HEART FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4500 09K292

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death| R| S