BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 2761234 · Received September 26, 2012

    Report

    Report Number
    2015691-2012-18359
    Event Type
    Injury
    Date Received
    September 26, 2012
    Date of Event
    August 14, 2012
    Report Date
    August 29, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL CODE = DEVICE NOT RETURNED. DESPITE ATTEMPTS TO RECEIVE FURTHER INFORMATION REGARDING THE DEVICE AND EVENT, NO ADDITIONAL INFORMATION OR SAMPLE FOR EVALUATION WAS RECEIVED. THEREFORE, THE ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. CONTINUED EFFORTS ARE BEING MADE TO OBTAIN ADDITIONAL DETAILS REGARDING THIS CASE. A SUPPLEMENTAL MDR WILL BE SUBMITTED IN THE EVENT NEW INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: A COPY OF THE PATHOLOGY REPORT WAS PROVIDED BY THE HOSPITAL ON (B)(6) 2012. PER THE REPORT, THIS DEVICE WAS EXPLANTED DUE TO PROSTHETIC AORTIC VALVE INSUFFICIENCY. ONLY A GROSS INSPECTION WAS PERFORMED WHICH SHOWED THE VALVE LEAFLETS MOVING FREELY. NO OTHER FINDINGS WERE PROVIDED.

    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 AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 1 YEAR AND 5 MONTHS. THE REASON FOR EXPLANT IS UNKNOWN. DESPITE ATTEMPTS TO RECEIVE FURTHER INFORMATION REGARDING THE DEVICE AND EVENT, NO ADDITIONAL INFORMATION OR SAMPLE FOR EVALUATION WAS RECEIVED. THERE HAVE NOT BEEN ANY ALLEGATIONS OF A MALFUNCTION OR DEFICIENCY RELATED TO THE EXPLANTED VALVE. THE DEVICE WAS REPLACED WITH ANOTHER EDWARDS BIOPROSTHETIC VALVE. NO OTHER DETAILS.

    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-10M3331

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R