BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 2771008 · Received October 3, 2012

    Report

    Report Number
    2015691-2012-18387
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    September 4, 2012
    Report Date
    September 4, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MODERATE CALCIFICATION WAS OBSERVED IN THE CUSP OF LEAFLET 1, MODERATE TO HEAVY IN THE CUSP OF LEAFLET 2 AND HEAVY CALCIFICATION IN CUSP OF LEAFLET 3. MINIMAL CALCIFICATION WAS OBSERVED ON THE FREE MARGIN OF LEAFLET 2. MODERATE TO HEAVY HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE OUTFLOW AND INTO THE ORIFICE BY THE GREATEST POINT BY APPROXIMATELY 9MM ON LEAFLET 3 AND 5MM ON LEAFLET 2. MODERATE HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE INFLOW AND INTO THE ORIFICE BY THE GREATEST POINT BY APPROXIMATELY 6MM ON LEAFLET 3 AND 4MM ON LEAFLET 2. HOST TISSUE IS MODERATE TO HEAVY AT THE STENT OUTFLOW, AND MODERATE AT THE STENT INFLOW. HOST TISSUE FUSED THE FREE MARGINS OF LEAFLETS 2 AND 3 AT COMMISSURE 3 BY 5MM ON THE INFLOW ASPECT, AND LEAFLETS 2 AND 3 AT COMMISSURE 3 BY 6MM ON THE OUTFLOW ASPECT. MISSING TISSUE WAS ALSO OBSERVED ON ALL 3 LEAFLETS, AN AREA OF APPROX 5MMX11MM ON LEAFLET 1, AN AREA OF APPROX 4MMX9MM ON LEAFLET 2 AND AN AREA OF APPROX 3MMX6MM ON LEAFLET 3. THE X-RAY DEMONSTRATES CALCIFICATION. (B)(4). THE DEVICE EVALUATION CONFIRMED CALCIFICATION AND HOST TISSUE OVERGROWTH AS THE PRIMARY CAUSES FOR THE REPORTED STENOSIS LEADING TO THIS EXPLANT. CALCIFICATION IS A WELL RECOGNIZED FAILURE MODE OF BIOPROSTHETIC VALVES. THE MECHANISMS FOR BIOPROSTHETIC HEART VALVE TISSUE CALCIFICATION ARE NOT FULLY UNDERSTOOD. MANY FACTORS CAN CONTRIBUTE TO THE ONSET AND PROPAGATION OF CALCIFICATION INCLUDING PATIENT RELATED (E.G. PATIENT AGE, DISEASE STATE, IMMUNE STATUS, AND OTHER CO-MORBIDITIES), PHARMACOLOGICAL, AND INTRINSIC PROPERTIES OF THE VALVE ITSELF. IT IS WIDELY UNDERSTOOD THAT PATIENTS WITH CHRONIC RENAL DISEASE AND PRIOR HISTORY OF CALCIFIC STENOSIS OF THE NATIVE VALVE MAY BE PREDISPOSED TO BIOPROSTHETIC CALCIFICATION. 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. THE MECHANISM OF HOST TISSUE GROWTH IN BIOPROSTHETIC HEART VALVES IS STILL NOT FULLY UNDERSTOOD. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION. THE AVAILABLE INFORMATION REVEALS NOTHING TO INDICATE A DEVICE QUALITY DEFICIENCY DURING MANUFACTURING.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE:THE EXPLANTED DEVICE HAS NOT YET BEEN EVALUATED,; HOWEVER, ITS RETURN AND ANALYSIS ARE ANTICIPATED.ATTEMPTS TO OBTAIN ADDIITONAL INFORMATION SUCH AS PATIENT MEDICAL HISTORY AND CONDITION OF EXPLANTED DEVICE AT SURGERY ARE ONGOING. ADDITIONAL INFORMATION, AS WELL AS STATEMENTS AND CONCLUSIONS, WILL BE REPORTED ONCE AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA HOSPITAL NURSE THAT A PATIENT UNDERWENT AN EXPLANT OF AN EDWARDS AORTIC BIOPROSTHETIC VALVE AFTER AN IMPLANT DURATION OF APPROXIMATELY 8 YEARS IMPLANT DURATION. NO REASON FOR EXPLANT WAS PROVIDED AT THIS TIME OF INITIAL REPORT. FOLLOW UPS ARE ONGOING.

    Description of Event or Problem · 1

    PATIENT RECORDS WERE RECEIVED WHICH INDICATED THE EXPLANT WAS DUE TO AORTIC STENOSIS. IT FURTHER INDICATED THAT THE PATIENT, "HAD DONE WELL SINCE THAT TIME (AVR IN (B)(6) 2005) UNTIL THIS YEAR WHERE HE HAS NOTICED INCREASE SOB AND SOME POSSIBLE DIZZINESS. THESE SYMPTOMS APPEARED WITH MINIMAL ACTIVITY SUCH AS WALKING UP A FLIGHT OF STAIRS. THE OPERATIVE NOTE INDICATES AS FOLLOWS: "THE AORTIC BIOPROSTHESIS WAS INSPECTED. LEAFLETS WERE THICKENED AND DENSELY CALCIFIED RENDERING IT SEVERELY STENOTIC. THE VALVE WAS CAREFULLY EXCISED PRESERVING THE ANNULAR TISSUE." AFTER THE PROCEDURE THE PATIENT WAS TAKEN UP TO THE CARDIOVASCULAR ICU IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS HEART-VALVE, REPLACEMENT DYE EDWARDS LIFESCIENCES 3000 4L1760

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| L| R