BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 2770808 · Received October 3, 2012

    Report

    Report Number
    2015691-2012-18384
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    August 31, 2012
    Report Date
    September 4, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: CUSTOMER REPORT OF STENOSIS WAS CONFIRMED. AS RECEIVED, HEAVY CALCIFICATION WAS OBSERVED ON LEAFLET 2 IN THE CUSP AREA. HEMATOMA WAS ALSO OBSERVED IN THE CUSP AREA OF LEAFLETS 1 AND 3 ON THE OUTFLOW ASPECT. FREE MARGINS OF LEAFLETS 1 AND 3 ALSO APPEARED THICKENED AT COMMISSURES 1 AND 3. FREE MARGIN OF LEAFLET 1 APPEARED THICKENED AT COMMISSURE 2. THE WIREFORM WAS ALSO EXPOSED AT COMMISSURE 1. DEVICE EVALUATION CONFIRMS CALCIFIC TISSUE DEGENERATION AS THE PRIMARY CAUSE OF THE REPORTED STENOSIS. 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. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. THE AVAILABLE INFORMATION SUGGESTS NOTHING TO INDICATE A DEVICE QUALITY DEFICIENCY THAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE:ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION (OPERATIVE DETAILS, PATIENT HISTORY...ETC) FROM THE HEALTHCARE PROVIDER ARE ONGOING.THE EXPLANTED DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION, THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED AT THIS TIME. ADDITIONAL INFORMATION AND ANALYSIS WILL BE REPORTED ONCE AVAILABLE.

    Description of Event or Problem · 1

    IT WAS LEARNED DIRECTLY FROM A CUSTOMER THAT A PATIENT WITH STENOSIS HAD THEIR 2800-21MM AORTIC VALVE EXPLANTED AND REPLACED. NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATES THIS VALVE WAS IMPLANTED FOR APPROXIMATELY 10 YEARS PRIOR TO THIS EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS HEART-VALVE, REPLACEMENT DYE EDWARDS LIFESCIENCES 2800 1M1799

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| L| S