BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 2103230 · Received May 25, 2011

    Report

    Report Number
    2015691-2011-15614
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    January 27, 2011
    Report Date
    April 27, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. THE SERIAL NUMBER WAS ALSO TRACED TO ITS STERILITY LOT, AND THE COMPLAINT DATABASE INDICATES NO RELATED ENDOCARDITIS/INFECTION COMPLAINTS ON ANY DEVICES PROCESSED UNDER THE SAME STERILITY LOT. DESPITE MULTIPLE FOLLOW-UP ATTEMPTS, THE HEALTHCARE PROVIDER DECLINED TO PROVIDE ANY ADDITIONAL INFORMATION SUCH AS THE TYPE/SOURCE OF INFECTION, DEVICE STATUS, AND PATIENT RELEVANT MEDICAL RECORDS; THEREFORE, NO ADDITIONAL INVESTIGATION CAN BE PERFORMED INTO THE ROOT CAUSE OF THIS REPORT. 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 DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 11 MONTHS. THE EXPLANTED AORTIC BIOPROSTHESIS WAS REPLACED BY ANOTHER EDWARDS' SAME-MODEL DEVICE. THROUGH FOLLOW-UP, THE HEALTHCARE PROVIDER INDICATED THAT THE VALVE WAS EXPLANTED DUE TO ENDOCARDITIS OF AN UNKNOWN SOURCE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000TFX R-09J2204

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R