BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS

    MDR report key: 3073711 · Received April 23, 2013

    Report

    Report Number
    2015691-2013-19894
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 25, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P000007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. AORTIC REGURGITATION (AR) IN BIOPROSTHETIC HEART VALVES, ALSO KNOWN AS AORTIC INSUFFICIENCY, OCCURS WHEN THE VALVE DOES NOT CLOSE PROPERLY IN DIASTOLIC PHASE, WHICH RESULTS IN RETROGRADE FLOW OF BLOOD INTO THE LEFT VENTRICLE. TRIVIAL/TRACE TO MILD AMOUNTS OF AR ARE NOT UNUSUAL POST OPERATIVELY IN BIOPROSTHETIC VALVES. THIS IS USUALLY TOLERATED BY THE PATIENTS. IF THE REGURGITATION WORSENS OR BECOMES SYMPTOMATIC, REOPERATION MAY BE NECESSARY. THE TYPE AND CAUSE OF REGURGITATION VARIES DEPENDING UPON MULTIPLE FACTORS. REGURGITATION WHICH DEVELOPS PROGRESSIVELY OVER TIME CAN BE DUE TO A NUMBER OF ISSUES INCLUDING PATIENT RELATED FACTORS OR STRUCTURAL VALVE DETERIORATION. HOWEVER, ADVANCES IN VALVE DESIGN AND BIOPROSTHETIC MATERIAL HAVE BEEN MADE WITH THE INTENTION OF REDUCING PERIVALVULAR OR CENTRAL LEAKS BY PROVIDING MORE EFFICIENT HEMODYNAMICS AND LONGER TISSUE DURABILITY. UNFORTUNATELY, THE DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS; THEREFORE, THE ROOT CAUSE OF THIS EVENT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    IN THIS CASE, IT WAS REPORTED THAT THE PROSTHETIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 8 YEARS. PER THE OP REPORT, THIS DEVICE WAS EXPLANTED DUE TO SEVERE PROGRESSIVE AORTIC INSUFFICIENCY. IT WAS NOTED THAT THIS PATIENT HAS A HISTORY INCLUDING LV HYPERTROPHY, HYPERTENSION, OBESITY, GOUT, KNOWN POLYPOSIS COLI, AND PRIOR TOBACCO ABUSE. THE DEVICE WAS REPLACED WITH A NEW EDWARDS BIOPROSTHETIC VALVE. THERE WAS SOME BLEEDING POST-IMPLANT; HOWEVER, THIS WAS RESOLVED. THE PATIENT WAS DISCHARGE HOME IN GOOD CONDITION. NO OTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175448 EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2500P

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R