BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS® PERIMOUNT® RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 2110606 · Received June 1, 2011

    Report

    Report Number
    2015691-2011-15664
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 6, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). CORRECTED BRAND NAME TO CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS. ADDITIONAL MANUFACTURER NARRATIVE: CORRECTING CONCLUSION STATEMENT TO: OVERALL, BASED ON THE INFORMATION AVAILABLE, THE REPORTED STENOSIS WAS FOUND TO BE DUE TO THE CALCIFICATION NOTED ON THE RETURNED VALVE. THE CALCIFICATION AND HOST TISSUE FOUND WERE LIKELY RELATED TO PATIENT FACTORS.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: EDWARDS RECEIVED (1) 2800/21MM VALVE. AS RECEIVED, THE VALVE EXHIBITED INTRINSIC AND EXTRINSIC, MODERATE TO HEAVY CALCIFICATION IN THE CUSP AREA OF LEAFLET 1, HEAVY CALCIFICATION IN THE CUSP AREA OF LEAFLET 2 AND MODERATE CALCIFICATION IN THE CUSP AREA OF LEAFLET 3. CALCIFICATION RESTRICTED MOBILITY IN THE LEAFLETS AND LED TO STENOSIS. SEVERAL OBSERVATIONS ARE VISIBLE AT COMMISSURE THREE: FREE MARGIN OF LEAFLET TWO TISSUE WAS SOFT AND 2MM SEPARATED INTO TWO LAYERS, LEAFLET THREE HAD DROPPED ABOUT 3 MM IN RESPECT TO LEAFLET TWO AND WIREFORM WAS EXPOSED ON THE COMMISSURE THREE POST AT THE OUTFLOW ASPECT. A CUT WAS VISIBLE ON LEAFLET THREE AT COMMISSURE 1 FROM THE FREE MARGIN INTO THE CUSP AREA, WHICH MEASURED ABOUT 3 MM IN LENGTH. THE EDGES OF THE LEAFLET WERE SHARP AND EVEN AT THE CUT REGION. MINIMAL HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE, AT BOTH ASPECTS AND INTO THE ORIFICE AT THE GREATEST POINT BY APPROXIMATELY 1-2 MM. HOST TISSUE WAS MINIMAL TO MODERATE AT THE STENT INFLOW AND MINIMAL AT THE STENT OUTFLOW. THE X-RAY DEMONSTRATED CALCIFICATION. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS AND FOUND NO NON CONFORMANCE WAS FOUND RELATED TO THE EVENT. OVERALL, BASED ON THE INFORMATION AVAILABLE, THE REPORTED STENOSIS WAS FOUND TO BE DUE TO THE CALCIFICATION AND HOST TISSUE NOTED ON THE RETURNED VALVE. THE CALCIFICATION AND HOST TISSUE WERE LIKELY RELATED TO PATIENT FACTORS.

    Additional Manufacturer Narrative · 1

    EVALUATION: METHOD (B)(4) - OTHER- PRODUCT HAS NOT RETURNED FOR EVALUATION. ADDITIONAL MANUFACTURER NARRATIVE: PENDING PRODUCT RETURN AND DEVICE HISTORY REVIEW. THE SOURCE OF THE REPORTED CALCIFICATION IS NOT KNOWN. 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.

    Description of Event or Problem · 1

    REPORTEDLY, THE SALES REPRESENTATIVE WAS CONTACTED BY THE HOSPITAL REGARDING AN AORTIC VALVE THAT WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 11 YEARS DUE TO STENOSIS. PER THE OPERATIVE REPORT, THE AORTIC VALVE WAS SEVERELY CALCIFIED ON ALL OF ITS LEAFLETS. THE VALVE WAS REMOVED AND REPLACED. THE PATIENT TOLERATED PROCEDURE AND WAS TAKEN TO THE CV ICU IN STABLE, BUT GUARDED CONDITION.

    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 0B0134

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R