BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS

    MDR report key: 2241398 · Received September 9, 2011

    Report

    Report Number
    2015691-2011-16155
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 10, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P000007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED ADDITIONAL MANUFACTURER NARRATIVE: THE DHR REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. THE DEVICE IS BEING RETURNED FOR EVALUATION BUT HAVE NOT BEEN RECEIVED. THERE IS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: AS RECEIVED THE VALVE EXHIBIT A TEAR THAT MEASURES TO APPROXIMATELY 12-13MM. HEAVY HOST TISSUE IS NOTED AT THE INFLOW RIM. NO INCONSISTENCIES DETECTED IN THE X-RAY, AS THE VALVE APPEARS TO BE FREE OF CALCIFICATION. IT IS CONCLUDED THAT THE TEAR MAY HAVE BEEN DUE TO NON CALCIFIC DEGENERATION. METHOD: X-RAY. ADDITIONAL MANUFACTURER NARRATIVE: NON-CALCIFIC BIOPROSTHETIC TISSUE DEGENERATION IS A CHRONIC EVENT WITH LARGE VARIABILITY AMONG IMPLANT RECIPIENTS. THE MECHANISM OF NON-CALCIFIC TISSUE DEGENERATION IS NOT FULLY UNDERSTOOD. CONSIDERING THAT TISSUE DEGENERATION IS GENERALLY CO-LOCALIZED WITH THE HIGH STRESS ZONE ON THE BIOPROSTHESIS, IT IS POSSIBLE THAT BOTH OPERATIONAL MECHANICAL STRESS AND BIOLOGICAL FACTORS, SUCH AS INFILTRATION OF PRO-INFLAMMATORY CELLS, MONONUCLEAR CELLS OR MACROPHAGES, MAY PLAY IMPORTANT ROLES IN LEAFLET TISSUE DEGENERATION. HOWEVER, THE TIME COURSE AND INVOLVEMENT OF OTHER FACTORS DURING THE EARLY STAGE OF THIS CHRONIC TISSUE DEGENERATIVE PROCESS REMAIN UNKNOWN.

    Description of Event or Problem · 1

    REPORTEDLY, THE 21MM VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 6 YEARS, 2 MONTHS (74.77 MONTHS) DUE TO AORTIC REGURGITATION (AR). THE CUSTOMER REPORTED THAT A PRIMA PLUS (B)(4) VALVE WAS IMPLANTED FOR AORTIC VALVE REPLACEMENT (AVR) TO CORRECT AORTIC STENOSIS (AS) ON (B)(6) 2005. ON (B)(6) 2011, DURING THE PATIENT'S ANNUAL FOLLOW UP, THERE WAS NO PROBLEM OBSERVED ON ECHOCARDIOGRAPHY. ON (B)(6) 2011, THE PATIENT VISITED THE DOCTOR FOR DYSPNEA. SYMPTOMS OF PULMONARY CONGESTION WERE OBSERVED. ON ECHOCARDIOGRAPHY, LEVEL IV REGURGITATION WAS OBSERVED. PATIENT WAS ADMITTED TO THE HOSPITAL IMMEDIATELY. ON (B)(6) 2011, THE DEVICE WAS EXPLANTED DUE TO AR AND PROSTHETIC VALVE DISFUNCTION (PVD). AT THE EXPLANT, A TEAR WAS OBSERVED ON THE LEFT CORONARY CUSP. A SJM EPIC VALVE WAS IMPLANTED AS A REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2500P 04B008

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R