BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS

    MDR report key: 1983003 · Received February 10, 2011

    Report

    Report Number
    2015691-2011-14763
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    January 7, 2011
    Report Date
    February 8, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MAUFACTURER ADDITIONAL NARRATIVE:IT WAS LEARNED THAT THE SUBJECT DEVICE HAS BEEN DISCARDED, AND WILL NOT BE RETURNED FOR EVALUATION.EDWARDS' RECORDS INDICATE NO OTHER REPORTED EVENTS, RELATED TO STERILIZATION/ENDOCARDITIS, ON ANY DEVICES MANUFACTURED WITHIN THE SAME STERILIZATION LOT OF THE PROVIDED SERIAL NUMBER.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: SURGEON IS UNABLE TO EXPLAIN THE SOURCE OF INFECTION. DEVICE RETURN STATUS IS PENDING. THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. THE OPERATIVE REPORT WAS PROVIDED AND STATED THAT THE DEVICE WAS EXPLANTED DUE TO ENDOCARDITIS. 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.

    Description of Event or Problem · 1

    REPORTEDLY, THE SALES REPRESENTATIVE RECEIVED AN EMAIL ON (B)(6) 2011 FROM THE HOSPITAL REGARDING A DEVICE EXPLANTED AFTER APPROXIMATELY 3 MONTHS DUE TO AN UNEXPLAINABLE INFECTION. PER THE (B)(6) 2011 OPERATIVE REPORT: THE PATIENT HAD AN AORTIC VALVE REPLACEMENT FOR AORTIC STENOSIS 3 MONTHS AGO. HE INITIALLY DID EXTREMELY WELL, BUT 2 WEEKS BEFORE THIS ADMISSION HE BEGAN HAVING FEVER WITH CHILLS. BLOOD CULTURES SHOWED THAT HE DID HAVE A GRAM-NEGATIVE STAPH EPIDERMIDIS. AN ECHO WAS DONE WHICH SHOWED HE HAD A LARGE VEGETATION ON THE PROSTHETIC VALVE AS WELL AS SOME AORTIC INSUFFICIENCY. THE AORTA WAS OPENED, AND THE VALVE WAS INSPECTED AND FOUND TO HAVE HAD VEGETATIONS GROWING ON 2 OF THE 3 LEAFLETS. THERE WERE NO PERFORATIONS IN THE VALVE. HOWEVER, ABOUT A 3RD OF THE POSTERIOR LEAFLET HAD DEHISCED WITH EXTENSIVE INVOLVEMENT WI THE SAME VEGETATIONS. THE VALVE WAS COMPLETELY EXCISED. THE OPERATIVE REPORT INDICATES THE SAME MODEL AND SIZE DEVICE WAS USED AS A REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000TFX R-10D0883

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R