BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 3191643 · Received June 26, 2013

    Report

    Report Number
    2015691-2013-20437
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 29, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: COPIES OF THE PATIENT'S MEDICAL RECORDS WERE RECEIVED WHICH SUPPORT THE INITIAL REPORT OF REGURGITATION/INSUFFICIENCY. PER THE OP REPORT, THE PATIENT WAS FOUND TO HAVE SIGNIFICANT EVIDENCE OF INTERVALVULAR LEAK WITH POSITIVE BLOOD CULTURES. THERE WAS THOUGHT TO THE POSSIBILITY OF THIS BEING A BACTERIAL ENDOCARDITIS AS WELL. DURING EXPLANTATION, THERE WAS NO OBVIOUS EVIDENCE OF AORTIC ROOT ABSCESS. THE ANNULUS WAS CLOSELY INSPECTED AND APPEARED TO BE INTACT AND WITHOUT EVIDENCE OF SOFT TISSUE DESTRUCTION. THE DEVICE WAS REPLACED WITH ANOTHER EDWARDS BIOPROSTHETIC VALVE. THERE IS CHANGE IN THE ORIGINAL CONCLUSION OF THIS CASE. NO FURTHER ACTIONS ARE BEING TAKEN.

    Additional Manufacturer Narrative · 1

    (B)(4). UNFORTUNATELY, THE EXPLANTED DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS; THEREFORE, THE SOURCE OF THE REPORTED CALCIFICATION AND TORN LEAFLET COULD NOT BE ASSESSED. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. ALTHOUGH THE ROOT CAUSE OF THIS EVENT CANNOT BE CONFIRMED, IT APPEARS THAT THE PATIENT'S REGURGITATION WAS LIKELY CAUSED BY THE REPORTED FINDINGS. CALCIFICATION IS A WELL RECOGNIZED FAILURE MODE OF BIOPROSTHETIC VALVES. THE MECHANISMS FOR BIOPROSTHETIC HEART VALVE TISSUE CALCIFICATION ARE NOT FULLY UNDERSTOOD. MANY FACTORS CAN CONTRIBUTE TO THE ONSET AND PROPAGATION OF CALCIFICATION INCLUDING PATIENT RELATED (E.G. PATIENT AGE, DISEASE STATE, IMMUNE STATUS, AND OTHER CO-MORBIDITIES), PHARMACOLOGICAL, AND INTRINSIC PROPERTIES OF THE VALVE ITSELF. IT IS WIDELY UNDERSTOOD THAT PATIENTS WITH CHRONIC RENAL DISEASE AND PRIOR HISTORY OF CALCIFIC STENOSIS OF THE NATIVE VALVE MAY BE PREDISPOSED TO BIOPROSTHETIC CALCIFICATION. THE TORN LEAFLET WAS ALSO LIKELY A RESULT OF THE DETERIORATING VALVE. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 10 YEARS, 5 MONTHS DUE TO AORTIC REGURGITATION WITH CALCIFICATION AND A TORN LEAFLET. THE EXPLANTED DEVICE WAS REPLACED WITH ANOTHER EDWARDS PROSTHETIC VALVE. NO OTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290126 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800 2L2041

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R