BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING WITH DURAFLO TREATMENT

    MDR report key: 1961884 · Received January 14, 2011

    Report

    Report Number
    2015691-2011-14684
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    October 1, 2010
    Report Date
    December 17, 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

    METHOD: DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: NO FURTHER DETAILS WERE PROVIDED. INVESTIGATION IS ON-GOING. THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: THE SURGEON'S RESPONSE INDICATED THAT THE DEVICE IS NOT AVAILABLE FOR RETURN. CONCLUSION: LATE PROSTHETIC VALVE ENDOCARDITIS, OCCURRING MORE THAN 60 DAYS AFTER SURGERY, IS USUALLY CAUSED BY AN INFECTION WHICH OCCURS ELSEWHERE IN THE BODY, AND THEN SEEDS THE VALVE. THE MOST FREQUENT CAUSES ARE DENTAL PROCEDURES, UROLOGICAL INFECTIONS AND INTERVENTIONS, AND INDWELLING CATHETERS. EDWARDS LIFESCIENCES HAS VALIDATED METHODS FOR STERILIZATION OF ALL DEVICES WHICH ENSURES PRODUCT STERILITY. IN THIS CASE, THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 2 YEARS DUE TO A STAPH INFECTION.

    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. IN THIS CASE, AN ANNULOPLASTY RING WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY TWO YEARS (23.90 MONTHS) AND WAS REPLACED WITH AN EDWARDS VALVE FOR UNKNOWN REASONS.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A RESPONSE WAS RECEIVED FROM THE SURGEON INDICATING THE DEVICE WAS EXPLANTED DUE TO ENDOCARDITIS OF THE NATIVE VALVE AND NOT DUE TO A DEVICE MALFUNCTION. THE INFECTION WAS REPORTED AS BACTERIAL, SOURCE ONLY KNOWN AS "STAPH".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING WITH DURAFLO TREATMENT ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4475 R-08F1242

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R