BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 2030135 · Received March 28, 2011

    Report

    Report Number
    2015691-2011-15102
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 28, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: X-RAY. EVALUATION SUMMARY: AS RECEIVED, THE VALVE EXHIBITS CUT OUT IN THE TISSUE OF ALL THREE LEAFLETS . THE SECTIONS THAT ARE MISSING, POSSIBLY FOR PATHOLOGY TESTING, MEASURE TO AN AVERAGE OF APPROXIMATELY 2-4MM AT THE FREE MARGIN BY 9-11MM INTO THE CUSP AREA. HEAVY CALCIFICATION IS EVIDENT IN THE CUSP AREA OF ALL THREE LEAFLETS. CALCIFICATION RESTRICTED MOBILITY IN THE LEAFLETS AND LED TO STENOSIS. MINIMAL HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE INFLOW AND INTO THE ORIFICE BY AT THE GREATEST POINT BY APPROXIMATELY 3MM. MINIMAL TO MODERATE HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE OUTFLOW AND INTO THE ORIFICE BY 3-4MM. HOST TISSUE IS MINIMAL TO MODERATE AT THE STENT INFLOW AND STENT OUTFLOW. SECTION OF THE SEWING RING IS CUT OFF ALONG LEAFLET 1 WHICH EXPOSED THE WIREFORM AT THE INFLOW ASPECT. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. 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, THE INVESTIGATION DID NOT INDICATE A QUALITY DEFICIENCY DURING THE MANUFACTURE OF THE DEVICE THAT MAY HAVE CONTRIBUTED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD: DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. CONCLUSION: DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. ADDITIONAL MANUFACTURER NARRATIVE: NO CONCLUSIVE INVESTIGATION FINDINGS HAVE BEEN REACHED AT THIS TIME; THE DEVICE HISTORY RECORD (DHR) REVIEW AND RETURNED DEVICE EVALUATION WILL BE REPORTED ONCE COMPLETED.

    Description of Event or Problem · 1

    REPORT INDICATES AN EDWARDS' VALVE WAS EXPLANTED DUE TO SEVERE MITRAL STENOSIS, AFTER AN IMPLANT DURATION OF APPROXIMATELY 80 MONTHS. IT WAS REPORTED THAT THE VALVE IS CALCIFIED, AND THE LEAFLETS WOULD NOT OPEN/CLOSE PROPERLY. OPERATIVE REPORT INDICATES MITRAL VALVULAR INSUFFICIENCY WAS DETECTED VIA A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). IT WAS ALSO NOTED THAT THE PATIENT'S NATIVE AORTIC VALVE WAS REPLACED DURING THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 690025MM 4D0610

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R