BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 4251786 · Received November 14, 2014

    Report

    Report Number
    2015691-2014-02707
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 14, 2014
    Report Date
    October 17, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE MFR REPORT # 2015691-2014-02708.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY THE EXPLANTED DEVICE WAS RETURNED TO EDWARDS FOR ANALYSIS. AS RECEIVED, HOST TISSUE WAS MINIMAL TO HEAVY ON THE TISSUE INFLOW, STENT INFLOW, AND STENT OUTFLOW. MINIMAL CALCIFICATION WAS OBSERVED ON THE HOST TISSUE ON ALL THREE (3) LEAFLETS AND WAS CONFIRMED VIA X-RAY. INCIDENTAL FINDING: THE WIREFORM WAS DISTORTED NEAR A COMMISSURE AND WAS EXPOSED NEAR TWO LEAFLETS ON THE INFLOW ASPECT. APPROXIMATELY 90% OF THE SEWING RING CIRCUMFERENCE WAS CUT. THESE DAMAGES ARE MOST DUE TO IMPLANT OR EXPLANT. METHOD: # X-RAY. ADDITIONAL MANUFACTURER NARRATIVE: THROUGH PRODUCT EVALUATION, THE CUSTOMER REPORT OF STENOSIS COULD NOT BE CONFIRMED. HOWEVER, MINIMAL TO HEAVY HOST TISSUE WAS OBSERVED ENCOMPASSING THE ENTIRETY OF THE DEVICE. IN THIS CASE, THE ROOT CAUSE FOR EXPLANT WAS LIKELY DUE TO HOST TISSUE OVERGROWTH, WHICH MAY HAVE CONTRIBUTED TO THE OBSERVED CLINICAL OBSERVATION OF STENOSIS. HOST TISSUE/PANNUS GROWTH IS A COMPLEX PROCESS TRIGGERED BY THE INTERACTION BETWEEN THE HOST AND THE DEVICE AND IS HIGHLY VARIABLE AMONG PATIENTS. LITERATURE DEFINES PANNUS AS A TYPE OF SCARRING AND TISSUE INGROWTH. IT IS NOT CURRENTLY POSSIBLE TO PREDICT THE OCCURRENCE AND SEVERITY FOR ANY GIVEN PATIENT WITH A BIOPROSTHETIC HEART VALVE. ABNORMAL OR SEVERE PANNUS GROWTH CAN EVENTUALLY AFFECT THE FUNCTION OF THE VALVE. ACCORDING TO LITERATURE, PANNUS TYPICALLY OCCURS BETWEEN 12 MONTHS TO 5 YEARS. SINCE THE MECHANISM OF HOST TISSUE GROWTH IN BIOPROSTHETIC HEART VALVES IS STILL NOT FULLY UNDERSTOOD, THE ROOT CAUSE FOR THE HOST TISSUE GROWTH FOR THIS PARTICULAR VALVE CANNOT BE DETERMINED AT THIS TIME. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. 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 THIS AORTIC BIOPROSTHETIC HEART VALVE WAS EXPLANTED AFTER TWO (2) YEARS, FIVE (5) MONTHS DUE TO STENOSIS. THIS WAS REPLACED WITH A 21MM MECHANICAL VALVE. AS REPORTED, THE PATIENT WAS LISTED IN STABLE CONDITION POST-OPERATIVELY. NO ADDITIONAL DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736929 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R