BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING

    MDR report key: 3901051 · Received June 30, 2014

    Report

    Report Number
    2015691-2014-01485
    Event Type
    Death
    Date Received
    June 30, 2014
    Date of Event
    August 24, 2013
    Report Date
    May 30, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K912554
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR RETURN AND EVALUATION AS IT REMAINS IMPLANTED AND THE DEVICE HISTORY RECORD (DHR) REVIEW IS IN PROCESS. THE SURGEON¿S RESPONSE INDICATED THE DEATH WAS NOT DEVICE RELATED; HOWEVER, THERE IS INSUFFICIENT INFORMATION TO IDENTIFY THE CAUSE OF THE SEPSIS AND MULTIORGAN FAILURE. OPERATIVE REPORT AND PATIENT HISTORY RECORDS HAVE BEEN REQUESTED. INVESTIGATION IS ON-GOING. IF NEW INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED. ENDOCARDITIS IS AN INFLAMMATION OF THE INSIDE LINING OF THE HEART CHAMBERS AND HEART VALVES. ENDOCARDITIS IS USUALLY THE RESULT OF A BLOOD INFECTION AS BACTERIA OR OTHER INFECTIOUS SUBSTANCES ENTER THE BLOODSTREAM AND TRAVEL TO THE HEART, WHERE THEY CAN SETTLE ON HEART VALVES. ENDOCARDITIS CAN POTENTIALLY LEAD TO DISORDERS SUCH AS SEVERE VALVULAR INSUFFICIENCY AND REGURGITATION. PATIENT RISK FACTORS FOR DEVELOPING ENDOCARDITIS INCLUDE INTRAVENOUS DRUG USE, CENTRAL VENOUS ACCESS LINES, PRIOR VALVE SURGERY, RECENT DENTAL SURGERY, RHEUMATIC FEVER, AND WEAKENED VALVES. EXISTING HEART DISEASE AND ABNORMALITIES INCREASE THE LIKELIHOOD OF DEVELOPING ENDOCARDITIS. ENDOCARDITIS IS TYPICALLY CLASSIFIED AS EITHER INFECTIVE OR NON-INFECTIVE, DEPENDING ON WHETHER A MICROORGANISM IS THE SOURCE OF THE INFLAMMATION OR NOT. ENDOCARDITIS IS OFTEN ASSOCIATED WITH NOSOCOMIAL (IE. HOSPITAL-ACQUIRED) SOURCES. NATIVE VALVE ENDOCARDITIS (NVE) OCCURS TO THE PATIENT'S NATIVE HEART VALVE(S) AND CAN BE CLASSIFIED AS EITHER ACUTE OR SUB-ACUTE. ACUTE NVE FREQUENTLY INVOLVES NORMAL VALVES AND USUALLY HAS AN AGGRESSIVE COURSE. TYPICALLY ACUTE NVE REQUIRES SURGICAL INTERVENTION. SUB-ACUTE NVE OFTEN AFFECTS DISEASED VALVES. IT IS USUALLY MORE INDOLENT THAN THAT OF THE ACUTE FORM AND MAY DEVELOP OVER MANY MONTHS AND CAN BE TREATED WITH ANTIMICROBIAL THERAPY. IN THIS CASE, THE CAUSE OF THIS PATIENT'S SEPSIS AND MULTISYSTEM ORGAN FAILURE HAS NOT BEEN CONFIRMED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER INFORMATION: THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Description of Event or Problem · 1

    EDWARDS LEARNED THROUGH THE IMPLANT PATIENT REGISTRY OF A PATIENT DEATH ONE (1) MONTH AND NINE (9) DAYS POST IMPLANT OF A 34MM ANNULOPLASTY RING. THROUGH INVESTIGATION, IT WAS LEARNED THE PATIENT EXPIRED DUE TO MULTIORGAN FAILURE AND SEPSIS. PATIENT REPORTEDLY HAD A HISTORY OF ENDOCARDITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380989 CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING RING, ANNULOPLASTY KRH EDWARDS LIFESCIENCES 4500

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death| H MI