BEUDAMED
    FDA Adverse Event Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 2223779 · Received August 25, 2011

    Report

    Report Number
    2015691-2011-16109
    Date Received
    August 25, 2011
    Date of Event
    June 21, 2011
    Report Date
    July 28, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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.DESPITE MULTIPLE FOLLOW-UPS WITH THE HEALTHCARE PROVIDER, NO ADDITIONAL INFORMATION WAS PROVIDED SUCH AS REASON FOR EXPLANT, OPERATIVE FINDINGS, AND DEVICE STATUS; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED INTO THE ROOT CAUSE OF THIS EVENT.THERE HAS BEEN NO INFORMATION TO SUGGEST A DEVICE QUALITY DEFICIENCY RELATED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE REASON FOR EXPLANTING THE DEVICE WAS INITIALLY PROVIDED ON (B)(6) 2011. PER THE SURGEON, THE DEVICE WAS REMOVED DUE TO PROSTHETIC AORTIC VALVE ENDOCARDITIS. IT WAS ALSO NOTED THAT THIS EVENT WAS DUE TO PATIENT RELATED FACTORS AND NOT A DEVICE MALFUNCTION. NO OTHER DETAILS REPORTED. DUE TO PATIENT PRIVACY REGULATIONS, THE HEALTH-CARE PROVIDER WAS NOT ABLE TO RELEASE ANY ADDITIONAL INFORMATION REGARDING THE EVENT (E.G. OPERATIVE REPORT, DISCHARGE SUMMARY, ETC.). UNFORTUNATELY, THE EDWARDS DEVICE WAS ALSO NOT RETURNED FOR ANALYSIS; THEREFORE, THE SOURCE OF THE INFECTION COULD NOT BE INVESTIGATED. 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. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    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 49 MONTHS, AND REPLACED WITH ANOTHER EDWARDS' PERICARDIAL VALVE. THE REASON FOR EXPLANT AND ADDITIONAL INFORMATION HAVE BEEN REQUESTED, BUT NOT YET PROVIDED BY THE HEALTHCARE PROVIDER.

    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 07C063

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention