BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS® PERIMOUNT® PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 2061645 · Received April 18, 2011

    Report

    Report Number
    2015691-2011-15253
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 22, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL MANUFACTURER NARRATIVE: UPDATED FILE WITH THE RECEIVED ECHO REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4) - LEAFLETS IMMOBILE, STENOSIS. EVALUATION METHOD, CONCLUSION: EVALUATION ANTICIPATED, BUT NOT YET BEGUN. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. THE DEVICE EVALUATION AND FINAL ANALYSIS OF THIS EVENT WILL BE REPORTED ONCE COMPLETED.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE RETURNED DEVICE WAS RECEIVED AND EVALUATED VISUALLY, BY LIGHT MICROSCOPE, AND X-RAY. AS RECEIVED THE VALVE EXHIBITS HEAVY CALCIFICATION IN THE CUSP AREA OF LEAFLET 3, MODERATE IN THE CUSP OF LEAFLET 2 AND MINIMAL IN THE CUSP AREA OF LEAFLET 1. AT THE FREE MARGINS, CALCIFICATION IS MODERATE TO HEAVY AT LEAFLETS 2 AND 3, AND MINIMAL IN THE FREE MARGIN OF LEAFLET 1. CALCIFICATION RESTRICTED MOBILITY IN THE LEAFLETS AND LED TO STENOSIS. MODERATE HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE OUTFLOW AND INTO THE ORIFICE AT THE GREATEST POINT BY APPROXIMATELY 5-6MM. MINIMAL HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE INFLOW AND INTO THE ORIFICE BY 2MM. HOST TISSUE IS MODERATE AT THE STENT INFLOW AND STENT OUTFLOW. METHOD: X-RAY. ADDITIONAL MANUFACTURER NARRATIVE: 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. 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. OVERALL, RESULTS OF THE INVESTIGATION DID NOT INDICATE A QUALITY DEFICIENCY DURING THE MANUFACTURE OF THE DEVICE THAT MAY HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    RECEIVED ECHO REPORT. STUDY RECOMMENDED A REDO MITRAL REPLACEMENT. THERE WAS MODERATE THICKENING AND CALCIFICATION OF THE PROSTHETIC MITRAL VALVE POSTERIOR LEAFLET WITH SOME PRESERVED MOBILITY OF THE ANTERIOR LEAFLET. MILD MITRAL REGURGITATION WAS PRESENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN EDWARDS' VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 92 MONTHS. THE RECEIVED OPERATIVE REPORT STATES, "PATIENT PRESENTED WITH ACUTE ONSET SHORTNESS OF BREATH AND HIS CARDIAC CATHETERIZATION, AS WELL AS ECHOCARDIOGRAM, SHOWED HIM TO HAVE PROSTHETIC VALVE STENOSIS. IN THE OPERATING ROOM WE FOUND TWO OUT OF THREE LEAFLETS OF THE PROSTHETIC VALVE TO BE TOTALLY IMMOBILE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS® PERIMOUNT® PLUS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900P 3D0833

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R