BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS BIOPROSTHETIC VALVED CONDUIT

    MDR report key: 3122998 · Received May 21, 2013

    Report

    Report Number
    2015691-2013-20142
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 23, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P870056/S006
    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. THE SURGEON HAS INDICATED THAT THIS EVENT WAS NOT RELATED TO A MALFUNCTION OF THE EDWARDS VALVE. UNFORTUNATELY, THE EXPLANTED DEVICE WAS DISCARDED BY THE HOSPITAL; THEREFORE, THE ROOT CAUSE OF THIS EVENT COULD NOT BE CONFIRMED. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    IN THIS CASE, IT WAS REPORTED THAT THE PULMONARY VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 10 YEARS AND 6 MONTHS DUE TO ENDOCARDITIS WITH STENOSIS. PER THE OP REPORT, THIS PATIENT HAS HAD 2 EPISODES OF ENDOCARDITIS WITH STREPTOCOCCUS ALPHA HEMOLYTIC TREATED WITH 4 AND 8 WEEKS OF ANTIBIOTICS RESPECTIVELY. ECHO SHOWED PULMONARY STENOSIS. THE VENTRICULAR FUNCTION HAS REMAINED ADEQUATE. THEREFORE, PATIENT HAD REDO-PULMONARY VALVE REPLACEMENT WITH ANOTHER EDWARDS VALVED CONDUIT. POST-OP TRANSVERSE ESOPHAGEAL ECHO DEMONSTRATED GOOD REPAIR WITH A WIDELY PATENT RIGHT VENTRICULAR OUTFLOW TRACT AND ENTRY INTO BOTH PA BRANCHES. THE SURGEON ALSO NOTED THAT THERE WAS NO MALFUNCTION OF THE EXPLANTED VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224557 CARPENTIER-EDWARDS BIOPROSTHETIC VALVED CONDUIT REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 4300

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization| L| R