BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 1940014 · Received December 28, 2010

    Report

    Report Number
    2015691-2010-14595
    Event Type
    Injury
    Date Received
    December 28, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 1, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: X-RAY. ADDITIONAL MANUFACTURER NARRATIVE: EVALUATION SUMMARY: AS RECEIVED TISSUE TEARS ARE EVIDENT IN THE VALVE. ALL THREE LEAFLETS AT ALL THREE COMMISSURES EXHIBIT TEARS AT THE FREE MARGIN THAT MEASURES BY AN AVERAGE OF 6-11MM ALONG THE ATTACHMENT. LEAFLET 1 EXHIBIT A TEAR AT THE FREE MARGIN AND ALONG THE ATTACHMENT AT COMMISSURE 3. AT THE OPPOSITE COMMISSURE 1, LEAFLET 1 EXHIBIT A NON THROUGH TEAR ALONG THE ATTACHMENT, A TEAR THAT HAS NOT PENETRATED THE ENTIRE THICKNESS OF THE TISSUE. THE DESCRIBED DISRUPTIONS IN LEAFLET 1 MEASURE BY APPROXIMATELY 5-6MM. LEAFLET 3 EXHIBIT TWO TEARS AT OPPOSITE COMMISSURES BY APPROXIMATELY 8-11MM. LEAFLET 2 EXHIBIT A TEAR AT COMMISSURE 2, AND A NON THROUGH TEAR AT COMMISSURE 3; THE DISRUPTIONS MEASURE TO 6-8MM. SWOLLEN AND THICKENED TISSUE IS DETECTED AT THE FREE MARGINS AND IN THE CUSP AREA ALONG THE ATTACHMENT IN ALL THREE LEAFLETS. MINIMAL CALCIFICATION IS DETECTED IN THE FREE MARGIN OF LEAFLET 1. COMMISSURE 3 APPEARS TO BE PUSHED IN, VISIBLE IN THE X-RAY. CALCIFICATION IS ALSO VISIBLE IN THE X-RAY AS WELL. THE VALVE WAS EXAMINED VISUALLY AND WITH A LIGHT MICROSCOPE. THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. SEQUENTIAL DESIGN IMPROVEMENTS HAVE INCREASED THE DURABILITY OF BIOPROSTHETIC VALVES. HOWEVER, FAILURES EARLIER THAN ANTICIPATED DUE OCCUR IN A SMALL NUMBER OF PATIENTS. ALTHOUGH BIOPROSTHETIC VALVES HAVE BEEN PROVEN TO HAVE EXCELLENT LONG TERM DURABILITY, FAILURE DOES OCCUR IN A SMALL NUMBER OF VALVES. STRUCTURAL VALVE DETERIORATION (SVD) MAY OCCUR AS A RESULT OF CALCIFICATION, NON-CALCIFIC DEGENERATION, DEHISCENCE OR FIBROSIS. IN THIS CASE, THE FAILURE MORE THAN LIKELY WAS DUE TO NON-CALCIFIC DEGENERATION. NON-CALCIFIC DEGENERATION IS CHARACTERIZED PHYSIOLOGICALLY BY MODERATE TO SEVERE REGURGITATION AND GROSSLY BY PARTIAL TO COMPLETE LOSS OF LEAFLET ARCHITECTURE. INVITRO AND IN-VIVO TESTING HAVE DEMONSTRATED CONSISTENT PATTERNS OF STRUCTURAL DAMAGE FROM NON-CALCIFIC DEGENERATION, WITH COLLAGEN LOSS WITHIN THE BELLIES OF THE LEAFLETS. THEREFORE, THIS MODE OF FAILURE INCLUDED CUSP TEARS AND PERFORATIONS WITHIN THE BODY OF THE CUSPS THAT WERE UNRELATED TO LEAFLET SEPARATION FROM THE STENT AND DISTINCT FROM TEARS ASSOCIATED WITH CALCIFICATION.

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. CONCLUSION: DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. ADDITIONAL MANUFACTURER NARRATIVE: NO MODEL, SIZE OR SERIAL NUMBER WAS PROVIDED BY THE HEALTH CARE PROVIDER. IT HAS BEEN REQUESTED THAT ONCE THE EVALUATION IS DONE, THE DEVICE WILL BE DISMANTLED FOR THE SERIAL NUMBER AND THE DHR REVIEW CAN BE DONE AT THAT TIME. NO PATIENT HEALTH HISTORY HAS BEEN PROVIDED. THE OPERATIVE REPORT AND A COPY OF THE PATHOLOGY REPORT HAS BEEN REQUESTED, BUT HAS NOT BEEN PROVIDED.

    Description of Event or Problem · 1

    THE SALES REP RECEIVED AN EMAIL FROM THE SURGEON THAT A DEVICE HAD BEEN EXPLANTED. THE SURGEON ESTIMATED THE IMPLANT DURATION TO BE APPROXIMATELY SEVEN YEARS AND REPORTED THAT A PRE-PUMP ECHO DISPLAYED MODERATE STENOSIS AND PARAVALVULAR LEAK. HOWEVER, THE SURGEON WAS NOT ABLE TO REPORT THE MODEL, SIZE OR SERIAL NUMBER OF THE DEVICE, ONLY THAT THE DEVICE WAS IMPLANTED WHEN THE PATIENT WAS (B)(6) YEARS OLD.

    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 3K1667

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R