BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS

    MDR report key: 3013761 · Received March 20, 2013

    Report

    Report Number
    2015691-2013-19607
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    January 31, 2013
    Report Date
    February 19, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. 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. UNFORTUNATELY, THE EXPLANTED DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS; THEREFORE, THE ROOT CAUSE OF THIS EVENT COULD NOT BE CONFIRMED. ALTHOUGH THE ROOT CAUSE OF THIS EVENT CANNOT BE CONCLUSIVELY DETERMINED, THE HEALTHCARE PROVIDER HAS INDICATED THAT THIS EVENT WAS DUE TO PATIENT RELATED FACTORS. THERE WAS NO DEVICE MALFUNCTION. THE INFECTION SOURCE WAS PROVIDED AS A HAEMOPHILUS SPECIES ACQUIRED S/P DENTAL WORK. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    IN THIS CASE, IT WAS REPORTED THAT THE AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 2 YEARS AND 8 MONTHS DUE TO PROSTHETIC VALVE ENDOCARDITIS. ACCORDING TO THE HEALTHCARE PROVIDER, THIS EVENT WAS DUE TO PATIENT RELATED FACTORS; THERE WAS NO DEVICE MALFUNCTION. THE INFECTION SOURCE WAS PROVIDED AS A HAEMOPHILUS SPECIES ACQUIRED S/P DENTAL WORK. THE EXPLANTED DEVICE WAS REPLACED WITH ANOTHER EDWARDS VALVE. NO OTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115411 CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| L| R