BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLACEMENT HEART VALVE

    MDR report key: 2103271 · Received May 25, 2011

    Report

    Report Number
    2015691-2011-15617
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    January 17, 2011
    Report Date
    April 26, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL #: THIS MODEL IS DISTRIBUTED OUTSIDE OF THE UNITED STATES AND IS BEING REPORTED AS SIMILAR TO MODEL 2800, WHICH IS MARKETED WITHIN THE UNITED STATES. (B)(4) - PARAVALVULAR LEAK. METHOD: DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED BY THE HOSPITAL. ON (B)(6) 2011, THE SURGEON RESPONDED THAT THE DEVICE WAS EXPLANTED DUE TO ENDOCARDITIS AND PARAVALVULAR LEAK. HE INDICATED THE REASON FOR EXPLANT WAS NOT RELATED TO A DEVICE MALFUNCTION. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. 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. NO INFORMATION REGARDING THE SOURCE AND TYPE OF INFECTION HAS BEEN PROVIDED BY THE HEALTH CARE PROVIDER. WITHOUT FURTHER INFORMATION FROM THE HEALTH CARE PROVIDER, WE ARE UNABLE TO CONCLUSIVELY DETERMINE THE ROOT CAUSE FOR 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, A 27MM VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 2 YEARS 9 MONTHS (33 MONTHS) AND WAS REPLACED BY A 23MM SIZE OF THE SAME MODEL DEVICE DUE TO ENDOCARDITIS AND PARAVALVULAR LEAK. THE SURGEON INDICATED IN HIS RESPONSE THAT THIS EXPLANT WAS NOT DUE TO A DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES SEE H10. 07B028

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R