BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT AORTIC PERICARDIAL BIOPROSTHESIS

    MDR report key: 2223772 · Received August 25, 2011

    Report

    Report Number
    2015691-2011-16106
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    June 28, 2011
    Report Date
    July 28, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - VEGETATIONS OF LEAFLETS. EVALUATION METHOD: DEVICE NOT RELEASED DUE TO PATIENT PRIVACY. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. THE COMPLAINT DATABASE INDICATES NO OTHER INFECTION/ENDOCARDITIS RELATED REPORTS RECEIVED FOR ANY DEVICES PROCESSED UNDER THE SAME STERILITY LOT OF THE SUBJECT DEVICE. THE HEALTHCARE PROVIDER INDICATES NO MALFUNCTION OF THE EDWARDS DEVICE. PROSTHETIC VALVE ENDOCARDITIS OCCURRING EARLY POST-OPERATIVELY, WITHIN 60 DAYS, IS USUALLY DUE TO PERIOPERATIVE BACTERIAL CONTAMINATION OF THE VALVE. MOREOVER, 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. IN THIS CASE, THE SOURCE OF INFECTION HAS NOT BEEN REPORTED BY THE HEALTHCARE PROVIDER, OR DETERMINED BY EDWARDS. EDWARDS LIFESCIENCES HAS VALIDATED METHODS FOR STERILIZATION OF ALL DEVICES WHICH ENSURES PRODUCT STERILITY. THE INVESTIGATION REVEALS INFORMATION TO SUGGEST A DEVICE QUALITY DEFICIENCY THAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS EXPLANT.

    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 AORTIC BIOPROSTHETIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 2 MONTHS. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE VALVE WAS EXPLANTED DUE TO RARE STAPH EPIDERMIDIS ENDOCARDITIS OF THE BIOPROSTHESIS. OPERATIVE INDICATIONS INDICATE PATIENT DEVELOPED POSITIVE BLOOD CULTURES, AND EVIDENCE OF PERIVALVULAR SPACE AND LARGE VEGETATIONS ON ALL 3 LEAFLETS OF THE AORTIC VALVE, BUT NO VALVULAR INSUFFICIENCY. ALSO INDICATED THAT THERE WAS A FAIRLY LARGE PERIVALVULAR ABSCESS ALONG THE NON CORONARY REGION OR ALONG THE LEFT CORONARY REGION.

    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 R-10M3354

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R