BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING

    MDR report key: 2133042 · Received June 17, 2011

    Report

    Report Number
    2015691-2011-15748
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    February 3, 2011
    Report Date
    June 7, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K083470
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE SURGEON HAS RESPONDED AND INDICATED THAT AN ANNULOPLASTY RING WAS EXPLANTED AND REPLACED WITH A MITRAL VALVE AFTER 8.67 MONTHS DUE TO ENDOCARDITIS. THE SOURCE AND TYPE OF INFECTION WERE NOT PROVIDED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED BY THE HOSPITAL. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. AT (B)(4) 2011, A THOROUGH SEARCH WAS CONDUCTED OF ALL DEVICES WITHIN THE MANUFACTURING AND STERILIZATION LOT REPORTED FOR THIS DEVICE, AND THERE WERE NO OTHER REPORTS OF A SIMILAR NATURE. 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 SOURCE AND TYPE OF INFECTION HAS NOT BEEN PROVIDED. WITHOUT SUFFICIENT INFORMATION, WE ARE UNABLE TO CONCLUSIVELY DETERMINE THE ROOT CAUSE FOR THE EXPLANT OF THIS DEVICE.

    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, AN 32MM ANNULOPLASTY RING WAS EXPLANTED AND REPLACED WITH A 29MM MITRAL VALVE AFTER AN IMPLANT DURATION OF 8 MONTHS 20 DAYS. IN HIS RESPONSE, THE HEALTH CARE PROVIDER HAS INDICATED THAT THE DEVICE WAS EXPLANTED DUE TO ENDOCARDITIS.

    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-10A0167

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R