BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS® PERIMOUNT MAGNA EASE¿ PERICARDIAL BIOPROSTHESIS

    MDR report key: 6648285 · Received June 16, 2017

    Report

    Report Number
    2015691-2017-01765
    Event Type
    Injury
    Date Received
    June 16, 2017
    Date of Event
    May 24, 2017
    Report Date
    May 29, 2017
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) WAS NOT REVIEWED AS THE REPORTED EVENT DOES NOT ALLEGE A MALFUNCTION THAT COULD BE RELATED TO A MANUFACTURING DEFICIENCY AND/OR ONE WAS NOT CONFIRMED THROUGH INVESTIGATION. 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. PMA/510(K)# P860057/S022.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: DEVICE WAS RETURNED AND EVALUATED. CUSTOMER COMPLAINT OF STENOSIS AND CALCIFICATION WAS CONFIRMED. X-RAY DEMONSTRATED HEAVY CALCIFICATION ON ALL THREE LEAFLETS, COMMISSURE 3 BENT, AND WIREFORM INTACT. CALCIFICATION RESTRICTED LEAFLET MOBILITY AND LED TO STENOSIS. HOST TISSUE ON THE STENT CIRCUMFERENCE WAS MINIMAL AT THE INFLOW AND OUTFLOW ASPECT. EXPOSED WIRE WAS OBSERVED NEAR LEAFLET 1 ON THE INFLOW AND OUTFLOW ASPECT AND NEAR COMMISSURE 1 ON THE OUTFLOW ASPECT. SEWING RING AND CLOTH HAD MULTIPLE CUTS AROUND THE VALVE.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL MDR WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION AS IT REMAINS IMPLANTED. THE CLINICAL OBSERVATION WAS UNABLE TO BE CONFIRMED. CALCIFICATION IS A WELL-RECOGNIZED FAILURE MODE OF BIOPROSTHETIC VALVES. 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. ALTHOUGH PATIENT FACTORS ARE BELIEVED TO PLAY A CRUCIAL ROLE IN THE DEVELOPMENT IN BIOPROSTHETIC TISSUE CALCIFICATION, THE UNDERLINE MECHANISM IS STILL NOT FULLY UNDERSTOOD. A MANUFACTURING RELATED ISSUE WAS NOT IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED; HOWEVER, IT IS LIKELY THAT PATIENT RELATED FACTORS AND THE PROGRESSION OF THE UNDERLYING VALVULAR DISEASE PATHOLOGY CONTRIBUTED TO THE EVENT. NO FURTHER CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS THROUGH THE USE OF EDWARDS QUALITY SYSTEMS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    EDWARDS LEARNED INTERVENTION WAS ALSO TAKEN DUE TO AORTIC STENOSIS.

    Description of Event or Problem · 1

    EDWARDS RECEIVED NOTIFICATION THAT A BIOPROSTHETIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROX 6 (SIX) YEARS AND 4 (FOUR) MONTHS FROM A PATIENT DUE TO CALCIFICATION OF LEAFLETS. THE PATIENT WAS NOTED TO BE IN GOOD CONDITION AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428131 CARPENTIER-EDWARDS® PERIMOUNT MAGNA EASE¿ PERICARDIAL BIOPROSTHESIS HEART-VALVE, REPLACEMENT DYE EDWARDS LIFESCIENCES 3000TFX25

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention