BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 2880439 · Received December 19, 2012

    Report

    Report Number
    2015691-2012-18900
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    December 4, 2012
    Report Date
    December 4, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: THE EXPLANTED DEVICE HAS BEEN ARRANGED FOR RETURN TO EDWARDS FOR EVALUATION, HOWEVER IT HAS NOT YET BEEN RECEIVED. EVALUATION FINDINGS WILL BE REPORTED ONCE COMPLETED. WITHOUT DEVICE EVALUATION, THE MODE OF THE REPORTED STENOSIS CANNOT BE IDENTIFIED. BIOPROSTHETIC VALVE STENOSIS CAN BE TRIGGERED BY VARIOUS PHYSIOLOGICAL MECHANISMS SUCH AS CALCIFIC TISSUE DEGENERATION, NON-CALCIFIC TISSUE DEGENERATION, AND/OR NON STRUCTURAL DYSFUNCTION (E.G. PANNUS GROWTH). ADDITIONAL INFORMATION AND ANALYSIS WILL BE PROVIDED ONCE AVAILABLE.

    Additional Manufacturer Narrative · 1

    METHOD = X-RAY. EVALUATION SUMMARY: AS RECEIVED, MINIMAL TO MODERATE CALCIFICATION WAS OBSERVED IN THE CUSP AREA OF LEAFLET 1, WHILE HEAVY CALCIFICATION WAS OBSERVED IN THE CUSP AREA OF LEAFLET 2 AND MODERATE CALCIFICATION WAS OBSERVED IN THE CUSP AREA OF LEAFLET 3. THE FREE MARGINS OF LEAFLETS 2 AND 3 EXHIBITED HEAVY CALCIFICATION, FREE MARGIN OF LEAFLET 1 EXHIBITED MINIMAL TO MODERATE CALCIFICATION. CALCIFICATION RESTRICTED MOBILITY IN THE LEAFLETS AND LED TO STENOSIS. HOST TISSUE WAS MINIMAL AT THE STENT OUTFLOW. DEVICE EVALUATION CONFIRMS CALCIFIC TISSUE DEGENERATION AS THE PRIMARY CAUSE OF THE REPORTED STENOSIS LEADING TO THIS EXPLANT. CALCIFIC DEGENERATION IS A COMMON CAUSE OF BIOPROSTHETIC HEART VALVE FAILURES. MANY FACTORS CONTRIBUTE TO THE ONSET AND PROPAGATION OF CALCIFICATION. THESE INCLUDE PATIENT FACTORS (AGE, DISEASE STATE, PHARMACOLOGICAL INTERVENTION, ETC. ), MECHANICAL STRESS RELATED TO THE VALVE'S HEMODYNAMIC PERFORMANCE, AND GLUTARALDEHYDE FIXATION OF TISSUE. OF THESE, THE FIXATION PROCESS IS A RELATIVELY MINOR CONTRIBUTOR TO CALCIFICATION FOR EDWARDS' TISSUE VALVES DUE TO ANTI-CALCIFICATION TREATMENTS DURING MANUFACTURING. THOUGH NUMEROUS STUDIES HAVE BEEN CONDUCTED ON PREVENTIVE CALCIFICATION STRATEGIES IN BIOPROSTHETIC HEART VALVES, THE CAUSES OF CALCIFICATION ARE NOT FULLY UNDERSTOOD. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. THERE HAS BEEN NO INFORMATION TO SUGGEST A DEVICE QUALITY DEFICIENCY THAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    REPORTED BY THE SURGEON THAT A (B)(6) WOMAN WITH HISTORY OF AORTIC VALVE STENOSIS STATUS POST A REPEAT BIOPROSTHETIC AORTIC VALVE REPLACEMENT SURGERY IN 2008, NOW PRESENTS WITH SEVERE PROSTHETIC STENOSIS (AVA 0.6 CM2) WHICH REQUIRED EXPLANTATION AND REPLACEMENT. THE EDWARDS VALVE WAS EXPLANTED AND REPLACED WITH A MECHANICAL BIOPROSTHESIS. THE EXPLANT OPERATIVE REPORT HAS NOT YET BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS HEART-VALVE, REPLACEMENT DYE EDWARDS LIFESCIENCES 3000TFX R-08F1253

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| L| R SPIRONOLACTONE 25 MG| GLUCOPHAGE 500 MG| HYDROXYREA 500 MG| ZOLOFT 50 MG| AMLODIPINE 5MG| PRAVASTATIN 20 MG| FUROSEMIDE 80 MG| METOPROLOL 25 MG