BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 3840045 · Received May 30, 2014

    Report

    Report Number
    2015691-2014-01263
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 1, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: CUSTOMER REASON FOR EXPLANT WAS UNKNOWN. HEAVY CALCIFICATION WAS OBSERVED IN THE CUSP AREA OF LEAFLET 3, MODERATE TO HEAVY CALCIFICATION WAS OBSERVED IN THE CUSP AREA OF LEAFLET 2 AND MINIMAL TO MODERATE CALCIFICATION WAS OBSERVED IN THE CUSP AREA OF LEAFLET 1. THE FREE MARGIN OF LEAFLET 2 EXHIBITED MINIMAL TO MODERATE CALCIFICATION. CALCIFICATION RESTRICTED MOBILITY IN THE LEAFLETS AND LED TO STENOSIS. LEAFLET 1 ALSO HAD A TORN AREA APPROX 8MMX5MM AT COMMISSURE 1. TORN AREA WAS NOT RETURNED WITH THE DEVICE. CALCIFICATION WAS OBSERVED NEAR THE REGION OF THE TORN AREA. MINIMAL HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE AT THE OUTFLOW ASPECT AND INTO THE ORIFICE AT THE GREATEST POINT BY APPROXIMATELY 8MM. HOST TISSUE WAS MINIMAL TO MODERATE AT THE STENT OUTFLOW AND MINIMAL AT THE STENT INFLOW. THROMBUS WAS OBSERVED ON LEAFLET 3. HEMATOMA WAS ALSO OBSERVED ON ALL THREE LEAFLETS AT THE OUTFLOW ASPECT. THE X-RAY DEMONSTRATED CALCIFICATION, COMMISSURE 1 WIREFORM DISTORTED. COMMISSURE 1 WIREFORM AND WIREFORM NEAR LEAFLET 1 WAS EXPOSED ON THE OUTFLOW ASPECT. SEWING RING ALSO HAD A CUT NEAR COMMISSURE 2. THESE DAMAGES ARE MOST LIKELY DUE TO EXPLANT. DESPITE REPEATED ATTEMPTS TO GET ADDITIONAL INFORMATION REGARDING THE PATIENT HISTORY OR CURRENT CONDITION, NO INFORMATION OR REPORTS HAVE BEEN MADE AVAILABLE. HOWEVER, THE DEVICE WAS RECEIVED AND EVALUATED WHICH INDICATED THE DEVICE WAS HEAVILY CALCIFIED. IN ADDITION, THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. 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. IN THIS CASE, THERE IS NO PATIENT HISTORY. THEREFORE, WE ARE UNABLE TO DETERMINE ROOT CAUSE FOR CALCIFICATION OF THIS DEVICE.

    Additional Manufacturer Narrative · 1

    EDWARDS HAS LEARNED THAT A 21MM AORTIC PERICARDIAL VALVE WAS EXPLANTED. DEVICE WAS RETURNED FOR EVALUATION. THROUGH FOLLOW UP WITH THE HEALTH CARE PROVIDER, A COPY OF THE OPERATIVE REPORT WAS RECEIVED. THE PATIENT WAS IDENTIFIED AND THE IMPLANT DURATION OF THIS DEVICE WAS DETERMINED NINE (9) YEARS, THREE (3) MONTHS AND SIX (6) DAYS (111.2 MONTHS). THE DIAGNOSIS FOR EXPLANT WAS AORTIC STENOSIS. THE 21MM MAGNA EASE WAS EXPLANTED AND REPLACED WITH A 23MM MAGNA EASE AORTIC PERICARDIAL VALVE. "THE ASCENDING AORTA WAS SOMEWHAT GENEROUS" WHICH ALLOWED FOR IMPLANT OF A LARGER VALVE. PREVIOUS CT SCAN DID NOT SHOW ANY HIGH-GRADE DISEASE OF THE ASCENDING AORTA. THE EXPLANT WAS PERFORMED WITHOUT ISSUE. POST BYPASS, THERE WAS GOOD HEART FUNCTION AND NO PARAVALVULAR ABNORMALITY.

    Description of Event or Problem · 1

    EDWARDS HAS LEARNED OF THE EXPLANT OF A 21MM AORTIC VALVE, MODEL 3000. REASON FOR EXPLANT WAS NOT REPORTED. NO PATIENT INFORMATION HAS BEEN PROVIDED. DEVICE WAS RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    EDWARDS HAS LEARNED THAT A 21MM AORTIC PERICARDIAL VALVE WAS EXPLANTED. DEVICE WAS RETURNED FOR EVALUATION. THROUGH FOLLOW UP WITH THE HEALTH CARE PROVIDER, A COPY OF THE OPERATIVE REPORT WAS RECEIVED. THE PATIENT WAS IDENTIFIED AND THE IMPLANT DURATION OF THIS DEVICE WAS DETERMINED NINE (9) YEARS, THREE (3) MONTHS AND SIX (6) DAYS (111.2 MONTHS). THE DIAGNOSIS FOR EXPLANT WAS AORTIC STENOSIS. THE 21MM MAGNA EASE WAS EXPLANTED AND REPLACED WITH A 23MM MAGNA EASE AORTIC PERICARDIAL VALVE. "THE ASCENDING AORTA WAS SOMEWHAT GENEROUS" WHICH ALLOWED FOR IMPLANT OF A LARGER VALVE. PREVIOUS CT SCAN DID NOT SHOW ANY HIGH-GRADE DISEASE OF THE ASCENDING AORTA. THE EXPLANT WAS PERFORMED WITHOUT ISSUE. POST BYPASS, THERE WAS GOOD HEART FUNCTION AND NO PARAVALVULAR ABNORMALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319608 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS HEART-VALVE, REPLACEMENT DYE EDWARDS LIFESCIENCES 3000

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R