BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS® PERIMOUNT® RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 2170541 · Received July 21, 2011

    Report

    Report Number
    2015691-2011-15894
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 21, 2011
    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

    EVALUATION: METHOD: DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN. CONCLUSION: DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: AS RECEIVED, THE VALVE EXHIBITED CUT OUT IN THE TISSUE. APPROXIMATELY 3-5MM OF TISSUE REMAINED INTACT ALONG THE ATTACHMENT IN LEAFLETS 1 AND 3. AT LEAFLET 2 A SECTION, SIMILAR IN SHAPE TO RECTANGLE, WAS CUT OFF. THE MISSING SECTION IN LEAFLET 2 AT COMMISSURE 2, MEASURES TO APPROXIMATELY 4MM ALONG THE FREE MARGIN INTO 2M IN THE CUSP AREA. IN THE TISSUE THAT REMAINED, CALCIFICATION WAS MINIMAL TO MODERATE IN THE CUSP AREA OF LEAFLET 2 AND MINIMAL IN THE CUSP AREA OF LEAFLETS 1 AND 3. MODERATE TO HEAVY HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE INFLOW AND INTO THE ORIFICE AT THE GREATEST POINT BY APPROXIMATELY 5MM. THIN LAYER OF HOST TISSUE OVERGROWTH ENCROACHED WAS DETECTED ONTO THE TISSUE OUTFLOW. HOST TISSUE WAS HEAVY AT THE STENT OUTFLOW. THE X-RAY DEMONSTRATED CALCIFICATION. EVALUATION: X-RAY. ADDITIONAL MANUFACTURER NARRATIVE: THE ROOT CAUSE FOR THE NOTED CALCIFICATION ON THE RETURNED DEVICE CANNOT CONCLUSIVELY BE DETERMINED. 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. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. THE VALVE REMAINED IMPLANTED FOR APPROXIMATELY 9 YEARS. OVERALL, THE INVESTIGATION RESULTS DID NOT INDICATE A PRODUCT QUALITY DEFICIENCY DURING THE MANUFACTURE OF THE DEVICE THAT MAY HAVE CONTRIBUTED TO THIS EVENT. IT IS LIKELY THAT PATIENT FACTORS CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN AORTIC VALVE WAS EXPLANTED DUE TO STENOSIS AFTER AN IMPLANT DURATION OF APPROXIMATELY (B)(6). PER THE OPERATIVE REPORT, THE PATIENT HAD AORTIC VALVE STENOSIS. THE BIOPROSTHETIC VALVE WAS CHARACTERIZED BY SEVERE CALCIFIC DEGENERATION. AFTER THE PROCEDURE, THE PATIENT WAS THEN TRANSPORTED INTUBATED IN STABLE CONDITION TO OPEN-HEART RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS® PERIMOUNT® RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800 1L1701

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R TRICUSPID RING REPAIR| MITRAL VALVE REPLACEMENT