BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT AORTIC PERICARDIAL BIOPROSTHESIS

    MDR report key: 2080919 · Received May 7, 2011

    Report

    Report Number
    2015691-2011-15479
    Event Type
    Injury
    Date Received
    May 7, 2011
    Date of Event
    March 2, 2011
    Report Date
    April 8, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT PROBLEM: DEVICE (B)(4) NO CODE AVAILABLE = PRIMARY VALVULAR DEHISCENCE EVALUATION: METHODS (B)(4) OTHER = DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. DESPITE MULTIPLE ATTEMPTS, THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO EDWARDS FOR EVALUATION. 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

    EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED 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 IT WAS LEARNED THAT THE EDWARDS' AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 47 MONTHS. INFORMATION WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. PATIENT WAS ADMITTED WITH MALAISE AND FEVERS, AND FOUND TO HAVE PROSTHETIC VALVE ENDOCARDITIS. OPERATIVE REPORT INDICATES, " PATIENT UNDERWENT COMPLEX FOURTH-TIME RE-DO STERNOTOMY WITH COMPLEX REPAIR OF MITRAL VALVE (ABSCESS DEBRIDEMENT, COMMISSURAL AND ANNULAR ABSCESS EXCLUSION, REATTACHMENT OF ANTERIOR MITRAL LEAFLET), AND AORTIC VALVE REPLACEMENT UTILIZING A 19 PERICARDIAL VALVE... THE VALVE WAS FOUND TO BE FREE FLOATING AND WAS EXCISED. THERE WAS FOUND TO BE A LARGE ABSCESS WHICH EXTENDED TO THE ANTERIOR MITRAL LEAFLET ATTACHMENT AND RESULTED IN DETACHMENT OF THIS AREA".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT AORTIC PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2700 6F1020

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R