BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 2991237 · Received March 6, 2013

    Report

    Report Number
    2015691-2013-19446
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    January 20, 2013
    Report Date
    February 5, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COPIES OF THE PATIENT'S MEDICAL RECORDS WERE RECEIVED WHICH INDICATE THAT THIS VALVE WAS EXPLANTED DUE TO ENDOCARDITIS. THIS PATIENT WAS ADMITTED TO HOSPITAL WITH SIGNS OF SEPSIS WHO UNDERWENT ECHOCARDIOGRAM REVEALING SIGNIFICANT ENDOCARDITIS OF BOTH HIS AORTIC (SUBJECT DEVICE) AND MITRAL VALVE. THE OPERATIVE FINDINGS NOTE DIFFUSE VEGETATIONS OF THE ENTIRE BIOPROSTHETIC AORTIC VALVE LEAFLETS. THE DEVICE WAS REPLACED WITH A NEW EDWARDS BIOPROSTHETIC VALVE. POST-OP CARDIAC FUNCTION APPEARED TO BE EXCELLENT. 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 PATIENT'S BLOOD CULTURE SHOWED ENTEROCOCCUS FAECALIS GROUP D. UNFORTUNATELY, THE EXPLANTED DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS; THEREFORE, THE SOURCE OF THE REPORTED ENDOCARDITIS COULD NOT BE CONFIRMED. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. DESPITE REPEATED ATTEMPTS TO RECEIVE FURTHER INFORMATION REGARDING THE DEVICE AND EVENT, NO ADDITIONAL INFORMATION OR SAMPLE FOR EVALUATION WAS RECEIVED. THEREFORE, THE ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED. THERE HAVE NOT BEEN ANY ALLEGATIONS OF A MALFUNCTION OR DEFICIENCY RELATED TO THE EXPLANTED VALVE. 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 7 YEARS AND 7 MONTHS. THE REASON FOR EXPLANT IS UNKNOWN. DESPITE REPEATED ATTEMPTS TO RECEIVE FURTHER INFORMATION REGARDING THE DEVICE AND EVENT, NO ADDITIONAL INFORMATION OR SAMPLE FOR EVALUATION WAS RECEIVED. THERE HAVE NOT BEEN ANY ALLEGATIONS OF A MALFUNCTION OR DEFICIENCY RELATED TO THE EXPLANTED VALVE. THE DEVICE WAS REPLACED WITH ANOTHER EDWARDS VALVE. NO OTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96083 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention