BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS® BIOPROSTHESIS

    MDR report key: 2870216 · Received December 12, 2012

    Report

    Report Number
    2015691-2012-18825
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    October 19, 2012
    Report Date
    November 14, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. CONCLUSION: 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.

    Additional Manufacturer Narrative · 1

    MODEL #: THIS DEVICE IS NOT DISTRIBUTED, MARKETED, OR SOLD IN THE U.S.; HOWEVER, IT IS SIMILAR TO MODEL NO. 6625, (B)(4), WHICH IS MARKETED IN THE U.S. CUSTOMER REPORT OF LEAFLETS NOT OPENING AND CLOSING WAS CONFIRMED. THROMBUS WAS OBSERVED ON THE RIGHT CORONARY AND LEFT CORONARY LEAFLETS ON THE OUTFLOW ASPECT. HOST TISSUE WAS MINIMAL ON THE TISSUE OUTFLOW AND ENCROACHED ONTO THE TISSUE BY A GREATEST DISTANCE OF 3MM. HOST TISSUE IS MINIMAL TO MODERATE AT THE STENT OUTFLOW. HOST TISSUE FUSED THE LEFT CORONARY AND NON CORONARY LEAFLETS, AS WELL AS THE NON CORONARY AND RIGHT CORONARY LEAFLETS ON THE OUTFLOW ASPECT. THROMBUS AND HOST TISSUE RESTRICTED LEAFLET MOVEMENT AND LED TO STENOSIS. NO VISIBLE CALCIFICATION OR WIREFORM DAMAGE WAS OBSERVED ON XRAY. THE DHR REVIEW IS IN PROGRESS THE OPERATIVE REPORT WAS SUBMITTED FOR THE IMPLANT ONLY AND REFERENCES REPLACEMENT DUE TO CHRONIC DIALYSIS, STENOSIS OF THE ANNULUS AND ENDOCARDITIS. PATIENT STATUS IS REPORTED AS SATISFACTORY.

    Description of Event or Problem · 1

    REPORTEDLY, THE VALVE WAS EXPLANTED AFTER AND IMPLANT DURATION OF APPROXIMATELY 19 MONTHS DUE TO HIGH GRADIENT. CUSTOMER REPORTED VALVE DEGENERATED. HIGH GRADIENT. LEAFLETS DO NOT OPEN AND CLOSE PROPERLY ANYMORE. EXPLANT OF THE VALVE ON THE (B)(6) 2012 AND IMPLANT OF A MECHANICAL MITRAL VALVE. PATIENT WELL AND DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS® BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES SEE H10 10A007

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention