BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 4221655 · Received November 3, 2014

    Report

    Report Number
    2015691-2014-02593
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    September 30, 2014
    Report Date
    October 8, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEW. ADDITIONAL MANUFACTURER NARRATIVE - ATTEMPTS TO OBTAIN EXPLANTED DEVICE AND RECORDS HAVE BEEN UNSUCCESSFUL. WITHOUT RETURN OF THE EXPLANTED DEVICE OR ADDITIONAL INFORMATION THE EXPLANT OF THIS VALVE CANNOT BE INVESTIGATED AND A 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.

    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 21MM BIOPROSTHETIC AORTIC VALVE, IMPLANTED APPROXIMATELY SIX (6) YEARS AND THREE (3) MONTHS, WAS EXPLANTED DUE TO UNKNOWN REASONS. THE EXPLANTED DEVICE WAS REPLACED WITH A 21MM BIOPROSTHETIC VALVE. THERE WERE NO COMPLICATIONS REPORTED.

    Description of Event or Problem · 1

    FURTHER INVESTIGATION REVEALED THAT THIS PATIENT HAD A COMPETITOR'S AORTIC VALVE PLACED THREE (3) YEARS PRIOR, WHICH WAS BEING REPLACED FOR SEVERE AORTIC STENOSIS. THEREFORE, THE EDWARDS 21MM AORTIC VALVE WAS LIKELY EXPLANTED AND REPLACED AT THAT TIME, WITH IMPLANT DURATION OF APPROXIMATELY THREE (3) YEARS. THE REASON FOR EXPLANT OF THE EDWARDS BIOPROSTHESIS REMAINS UNKNOWN. HOWEVER, PATIENT HAS KNOWN HISTORY OF PATIENT PROSTHESIS MISMATCH FOR THE AORTIC VALVE POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703119 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R