BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 3895449 · Received June 25, 2014

    Report

    Report Number
    2015691-2014-01460
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS BECAUSE IT REMAINS IMPLANTED IN THE PATIENT, AS THIS WAS A VALVE-IN-VALVE (VIV) PROCEDURE. WITHOUT RETURN OF THE DEVICE, EDWARDS IS UNABLE TO CONCLUSIVELY DETERMINE THE ROOT CAUSE FOR THIS EVENT. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. DEVICE REMAINS IMPLANTED. BASED ON THE INFORMATION PROVIDED, THE CLINICAL OBSERVATION OF REGURGITATION WAS LIKELY SECONDARY TO CALCIFICATION. MANY FACTORS CONTRIBUTE TO THE ONSET AND PROPAGATION OF CALCIFICATION. THESE INCLUDE PATIENT FACTORS (AGE, DISEASE STATE, PHARMACOLOGICAL INTERVENTION, ETC.) AND MECHANICAL STRESS RELATED TO THE VALVE¿S HEMODYNAMIC PERFORMANCE. IN THIS CASE, PATIENT FACTORS MAY HAVE CONTRIBUTED TO THIS EVENT. THOUGH NUMEROUS STUDIES HAVE BEEN CONDUCTED ON PREVENTIVE CALCIFICATION STRATEGIES IN BIOPROSTHETIC HEART VALVES, THE CAUSES OF CALCIFICATION ARE NOT FULLY UNDERSTOOD AND THERE ARE STILL NO MECHANISMS OR MEDICAL THERAPIES WHICH FULLY PREVENT BIOPROSTHESES FROM CALCIFYING. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION THAT A TRANSCATHETER VALVE WAS IMPLANTED INTO A SURGICAL VALVE (VALVE-IN-VALVE) AFTER AN IMPLANT DURATION OF TEN (10) YEARS, FIVE (5) MONTHS. THE REASON FOR RE-OPERATION WAS DUE TO AORTIC INSUFFICIENCY, POSSIBLY FROM A CALCIFIED LEAFLET. THERE WERE NO REPORTED COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370023 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R