BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 3011478 · Received March 19, 2013

    Report

    Report Number
    2015691-2013-19585
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 18, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD = X-RAY. DEVICE EVALUATION SUMMARY: AS RECEIVED, MINIMAL TO MODERATE HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE AT THE INFLOW ASPECT AND INTO THE ORIFICE AT THE GREATEST POINT BY APPROXIMATELY 2MM. MODERATE TO HEAVY HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE AT THE OUTFLOW ASPECT AND INTO THE ORIFICE AT THE GREATEST POINT BY APPROXIMATELY 8MM. HOST TISSUE WAS MODERATE TO HEAVY AT THE STENT OUTFLOW AND MINIMAL AT THE STENT INFLOW. HOST TISSUE FUSED LEAFLETS 1 AND 3 AT COMMISSURE 1 BY 4MM AND LEAFLETS 2 AND 3 AT COMMISSURE 3 BY 8 MM AT THE OUTFLOW ASPECT. IT ALSO RESTRICTED MOBILITY IN THE LEAFLETS WHICH LEAD TO STENOSIS. MOREOVER, MINIMAL CALCIFICATION WAS OBSERVED IN THE CUSP AREA OF LEAFLET 3. THE FREE MARGIN OF LEAFLET 2 HAD MINIMAL CALCIFICATION, FREE MARGIN OF LEAFLET 3 HAD MINIMAL TO MODERATE CALCIFICATION. NO INCONSISTENCIES DETECTED IN THE X-RAY AS THE WIREFORM IS INTACT. DEVICE EVALUATION CONFIRMS MODERATE TO HEAVY HOST TISSUE OVERGROWTH (PANNUS) AS THE PRIMARY CAUSE OF THE REPORTED STENOSIS AND REGURGITATION LEADING TO THIS EXPLANT. 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. THE MECHANISM OF HOST TISSUE GROWTH IN BIOPROSTHETIC HEART VALVES IS STILL NOT FULLY UNDERSTOOD. THERE IS NO INFORMATION TO SUGGEST A DEVICE QUALITY DEFICIENCY THAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN EDWARDS MITRAL BIOPROSTHETIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 8 YEARS DUE TO PROSTHETIC MITRAL STENOSIS AND INSUFFICIENCY. PATIENT UNDERWENT REDO MITRAL VALVE REPLACEMENT WITH A MECHANICAL VALVE, TRICUSPID VALVE REPLACEMENT WITH ANNULOPLASTY RING, AND CABG. OPERATIVE REPORT INDICATES, " THERE APPEARED TO BE SIGNIFICANT PANNUS UNDERNEATH THE VALVE AND SOME CALCIFICATION OF THE LEAFLETS THEMSELVES. OPERATIVE FINDINGS INDICATES: " EXPOSURE OF THE MITRAL VALVE WAS SOMEWHAT DIFFICULT, BUT EVENTUALLY SUCCESSFULLY ACCOMPLISHED, AND A 27 MM MECHANICAL VALVE WAS PLACED." ALSO NOTED THAT THE PATIENT TOLERATED THE PROCEDURE WELL, THERE WERE NO INTRAOPERATIVE COMPLICATIONS, DISCHARGED BACK TO THE SURGICAL ICU IN SERIOUS CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114316 CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900P

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L| R