BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 3944104 · Received July 18, 2014

    Report

    Report Number
    2015691-2014-01626
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 1, 2014
    Report Date
    June 19, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE EXPLANTED DEVICE WAS RETURNED TO EDWARDS FOR ANALYSIS. AS RECEIVED, EIGHT (8) TISSUE PIECES AND TWO CLOTH PIECES WERE RECEIVED; THESE WERE NOT ATTACHED TO THE FRAME. HEAVY CALCIFICATION WAS OBSERVED IN SIX (6) OF THE EIGHT (8) TISSUE PIECES. HOST TISSUE WAS ALSO OBSERVED ON SOME PIECES. NO VISIBLE DAMAGE WAS OBSERVED ON THE WIREFORM; HOWEVER, THE WIRE BAND APPEARED DISTORTED ON ONE SIDE - LIKELY DUE TO EXPLANT. METHOD: X-RAY. RESULTS: DEVICE RECEIVED IN A CONDITION THAT MADE ANALYSIS IMPOSSIBLE. THE CUSTOMER REPORT OF STENOSIS COULD NOT BE CONFIRMED DUE TO THE CONDITION OF THE RETURNED VALVE. HOWEVER, HEAVY CALCIFICATION WAS OBSERVED ON MULTIPLE PIECES OF THE TISSUE. 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. 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.

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE IS ANTICIPATED TO BE RETURNED TO EDWARDS AND AN EVALUATION OF THE PRODUCT IS CURRENTLY PENDING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED AN AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF EIGHT (8) YEARS, FOUR (4) MONTHS DUE TO STENOSIS AND INSUFFICIENCY. THIS WAS REPLACED WITH A 25 MM PERICARDIAL BIOPROSTHESIS. THERE WERE NO COMPLICATIONS AND THE PATIENT WAS TAKEN TO THE ICU IN CRITICAL BUT STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422811 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R