BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS

    MDR report key: 2843065 · Received November 21, 2012

    Report

    Report Number
    2015691-2012-18701
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 5, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY ATTACHED: AS RECEIVED, MODERATE HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE AT THE OUTFLOW ASPECT AND INTO THE ORIFICE AT THE GREATEST POINT BY APPROXIMATELY 6MM. FREE MARGIN OF LEAFLET 1 WAS FOLDED OVER DUE TO HOST TISSUE. HOST TISSUE WAS HEAVY AT THE STENT OUTFLOW AND MINIMAL AT THE STENT INFLOW. LEAFLET 1 HAD A SUTURE THREAD PENETRATING THE ENTIRE THICKNESS OF THE LEAFLET AT THE CUSP AREA. (B)(4) WAS ALSO EXPOSED. NO VISIBLE DAMAGE TO WIREFORM. ADDITIONAL MANUFACTURER NARRATIVE: AT THE TIME OF THE REPORT, THE PATIENT STATUS WAS LISTED AS "STABLE". NO UPDATE ON THE PATIENT STATUS HAS BEEN DISCLOSED. 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. A CERTAIN DEGREE OF HOST TISSUE GROWTH IS EXPECTED. HOWEVER, 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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN. ADDITIONAL MANUFACTURER NARRATIVE: DEVICE IS IN THE PROCESS OF BEING PROCESSED FOR SHIPPING OUT OF OUR FACILITY IN (B)(4) TO OUR PRODUCT EVALUATION LAB IN THE U.S. SERIAL NUMBER PROVIDED BY HEALTH CARE PROVIDER. THE DHR REVIEW WAS COMPLETED. THIS DEVICE MET ALL SPECIFICATIONS. DEVICE NAME CORRECTED TO CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS. MODEL NO. CORRECTED FROM 6900P TO 7000TFX. PMA/510(K) # CORRECTED TO P860057/S029.

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: CURRENTLY, THE DEVICE REMAINS IMPLANTED BUT THE EXPLANT IS EXPECTED. NO DEVICE HISTORY RECORD REVIEW (DHR) CAN BE DONE UNTIL THE SERIAL NUMBER IS KNOWN. IT MAY NEED TO BE DISMANTLED ONCE RECEIVED, TO GAIN THE SERIAL NUMBER, UNLESS THIS INFORMATION IS PROVIDED AFTER EXPLANT. EXPLANT DATE IS UNKNOWN AT THIS TIME.

    Description of Event or Problem · 1

    THE SURGEON WAS PLANNING TO RE-OPERATE THIS PATIENT FOR A VALVE-IN-VALVE PROCEDURE DUE TO MITRAL VALVE INSUFFICIENCY. CUSTOMER REPORTED, THE DEVICE WAS IMPLANTED APPROXIMATELY 3 YEARS AGO. THE SURGEON IS SUSPECTING THE INSUFFICIENCY IS LIKELY CAUSED BY A LEAFLET TEAR. THE SURGEON HAS NOT EXAMINED THE CASE IN DETAIL YET, THE LEAFLET TEAR IS JUST A SUSPICION. ONE YEAR AGO, THIS PATIENT HAD AN AORTIC VALVE REPLACEMENT DUE TO ENDOCARDITIS TO THE NATIVE VALVE AND RECEIVED AN EDWARDS' MAGNA EASE SIZE 19 VALVE. ON THAT OCCASION, AN ECHO WAS PERFORMED AND THE MITRAL VALVE WAS WORKING WELL. AT THE MOMENT, THE AORTIC VALVE IS WORKING WELL. PATIENT HAD ALSO 2 STROKES AND NOW SHE WALKS WITH DIFFICULTIES. NO OTHER VISIBLE COMORBIDITIES. (B)(6) 2012, THE SURGEON HAS DECIDED TO EXPLANT THE VALVE. THE VALVE REPLACEMENT WILL BE PERFORMED IN THE NEXT DAYS. THE DEVICE WILL BE RETURNED FOR EVALUATION. THE MODEL WAS ALSO IDENTIFIED AS A 6900 PERIMOUNT MITRAL VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 7000TFX 09K273

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Life Threatening| O