BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 2022655 · Received March 17, 2011

    Report

    Report Number
    2015691-2011-15039
    Event Type
    Injury
    Date Received
    March 17, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 17, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD/RESULT: DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. ADDITIONAL MANUFACTURER NARRATIVE: THE RETURNED DEVICE EVALUATION RESULTS AND CONCLUSIONS, AS WELL AS DEVICE HISTORY RECORD REVIEW, WILL BE REPORTED ONCE COMPLETED.

    Additional Manufacturer Narrative · 1

    METHOD: X-RAY. EVALUATION SUMMARY: AS RECEIVED THE VALVE EXHIBITS HEAVY CALCIFICATION IN THE CUSP AREA OF LEAFLET 1, AND MODERATE TO HEAVY CALCIFICATION IN THE CUSP AREA OF LEAFLET 2 AND 3. CALCIFICATION IS MINIMAL TO MODERATE AT THE FREE MARGINS OF LEAFLETS 2 AND 3. CALCIFICATION RESTRICTED MOBILITY IN THE LEAFLETS AND LED TO STENOSIS. FURTHERMORE, THE EXPLANTED VALVE EXHIBITS MINIMAL HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE INFLOW AND INTO THE ORIFICE BY AT THE GREATEST POINT BY APPROXIMATELY 2MM. HOST TISSUE IS MINIMAL TO MODERATE AT THE STENT INFLOW. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO RELATED NON CONFORMANCES. 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. 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 INVESTIGATION DID NOT INDICATE A QUALITY DEFICIENCY DURING THE MANUFACTURE OF THIS DEVICE THAT MAY HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN EDWARDS VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 62 MONTHS. THE PATIENT'S CONDITION WAS OK AFTER SURGERY. IT WAS LEARNED THAT THE EXPLANT WAS NEEDED TO TREAT SEVERE PROSTHETIC VALVE AORTIC REGURGITATION AND STENOSIS POST PREVIOUS AVR AND CABG IN 2005. PER OPERATIVE REPORT, PATIENT WAS FOUND TO HAVE A VERY HIGH GRADIENT ACROSS THE VALVE, AND A NARROW AREA WITH SEVERE AORTIC REGURGITATION AND AORTIC STENOSIS...THE VALVE WAS IDENTIFIED TO BE CALCIFIED AND STENOTIC, AS WELL AS THICK, WHICH WAS ACCOUNTING FOR ITS REGURGITATION...THE VALVE WAS FURTHER DEBRIDED OF THE INGROWTH TO THE PROSTHETIC VALVE CUFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 280023MM 5A0003

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R