BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 2032160 · Received March 28, 2011

    Report

    Report Number
    2015691-2011-15113
    Event Type
    Death
    Date Received
    March 28, 2011
    Report Date
    February 28, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED, AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. NO QUALITY DEFICIENCIES DETECTED WITH THE SUBJECT EDWARDS' DEVICE.

    Additional Manufacturer Narrative · 1

    UNFORTUNATELY, THE EDWARDS DEVICE WAS NOT RETURNED FOR ANALYSIS. DUE TO PATIENT PRIVACY REGULATIONS, THE HOSPITAL WOULD NOT RELEASE ANY ADDITIONAL INFORMATION REGARDING THE PATIENT'S DEATH. THE DEVICE HISTORY RECORD (DHR) REVIEW IS CURRENTLY IN PROCESS.

    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 REPORTED THAT THE PATIENT HAS EXPIRED. THE DATE OF PATIENT'S DEATH AND IMPLANT DURATION WERE NOT PROVIDED. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, A COPY OF THE PATIENT'S OPERATIVE REPORT (PROCEDURE DATE (B)(6) 2010; DATE OF IMPLANT) WAS RECEIVED. ACCORDING TO THE OPERATIVE REPORT, THE PATIENT PRESENTED WITH AORTIC INSUFFICIENCY AND THEREFORE, HAD AN AORTIC VALVE REPLACEMENT PERFORMED USING THE EDWARDS BIOPROSTHETIC VALVE. OF NOTE, THE PATIENT ALSO HAD MITRAL VALVE REPLACEMENT (NON-EDWARDS DEVICE) PERFORMED FOR MITRAL REGURGITATION. THE PATIENT LEFT THE OPERATION IN CRITICAL BUT STABLE CONDITION. NO OTHER DETAILS WERE PROVIDED. UNFORTUNATELY, THE CAUSE OF DEATH REMAINS UNKNOWN. FURTHERMORE, THERE HAVE NOT BEEN ANY ALLEGATIONS OF A PRODUCT MALFUNCTION, OR THAT THE EDWARDS DEVICE CAUSE OR CONTRIBUTED TO THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX R-10H2101

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death