BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 4885194 · Received July 1, 2015

    Report

    Report Number
    2015691-2015-01592
    Event Type
    Injury
    Date Received
    July 1, 2015
    Date of Event
    May 7, 2015
    Report Date
    June 3, 2015
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION AND RECORDS HAVE BEEN UNSUCCESSFUL. WITHOUT RECEIPT OF DEVICE OR ADDITIONAL INFORMATION THE REPORTED EXPLANT CANNOT BE INVESTIGATED AND ROOT CAUSE CANNOT BE DETERMINED. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE - THE REPORTED CLINICAL OBSERVATION COULD NOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED TO MANUFACTURER. 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 RECEIVED ADDITIONAL INFORMATION RECEIVED INDICATES THAT AN AORTIC BIOPROSTHETIC VALVE WAS EXPLANTED DUE TO MITRAL VALVE ENDOCARDITIS AFTER AN IMPLANT DURATION OF APPROXIMATELY FIVE (5) MONTHS. AT FIRST THE AORTIC VALVE SHOWED NO REGURGITATION BUT UPON INSPECTION IT WAS FOUND THAT THE ENTIRE AORTIC ANNULUS WAS INFECTED TO THE EXTENT THAT ONLY TWO SUTURES HAD TO BE CUT TO REMOVE THE VALVE. THE PATIENT WAS IMPLANTED WITH AN AORTIC BIOPROSTHETIC VALVE. THE PATIENT WAS REPORTED IN SERIOUS BUT STABLE CONDITION.

    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, EDWARDS RECEIVED INFORMATION THAT A 23MM BIOPROSTHETIC AORTIC VALVE, IMPLANTED APPROXIMATELY FIVE (5) MONTHS, WAS EXPLANTED DUE TO UNKNOWN REASONS. THE EXPLANTED DEVICE WAS REPLACED WITH A 27MM. AN AORTIC VALVE USED IN THE MITRAL POSITION WAS ALSO EXPLANTED. ATTEMPTS TO OBTAIN DEVICE AND ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. THERE WERE NO REPORTED COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427820 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX 3775437

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R