BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS

    MDR report key: 2980723 · Received February 27, 2013

    Report

    Report Number
    2015691-2013-19401
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 29, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CODES: METHOD: OTHER = X-RAY. ADDITIONAL MANUFACTURER NARRATIVE: THE EXPLANTED DEVICE WAS RETURNED TO EDWARDS AND UNDERWENT GROSS VISUAL EVALUATION. IN ADDITION, HISTOLOGICAL TESTING WAS PERFORMED ON THE RETURNED DEVICE TISSUE. DEVICE EVALUATION AND HISTOLOGICAL TESTING: AS RECEIVED, EXTENSIVE HOST TISSUE GROWTH IS OBSERVED ON THE OUTFLOW SIDE OF THE LEAFLETS, INCLUDING SOME APPARENT NATIVE CHORDAE TENDINAE. MODERATE TO SEVERE TISSUE CALCIFICATION IS ALSO EVIDENT IN TWO OF THE LEAFLETS. HISTOLOGY TESTING CONFIRMED THE PRESENCE OF BIOPROSTHETIC LEAFLET TISSUE CALCIFICATION AND HOST PANNUS OVERGROWTH ON THE EXPLANT. HISTOLOGY ALSO CONFIRMED THAT PART OF THE HOST NATIVE MITRAL VALVULAR APPARATUS WAS ATTACHED TO THE SEWING RING OF THE BIOPROSTHESIS. SUMMARY AND CONCLUSIONS: ALTHOUGH NO FUNCTIONAL TESTING WAS PERFORMED, THE HOST TISSUE OVERGROWTH AND BIOPROSTHETIC LEAFLET CALCIFICATION APPEARED TO BE SUFFICIENTLY SEVERE TO BE RESPONSIBLE FOR THE STENOSIS REPORTED IN VIVO. BIOPROSTHETIC LEAFLET CALCIFICATION AND HOST TISSUE OVERGROWTH ARE TWO COMMON CHRONIC FAILURE MODES IN BIOPROSTHETIC HEART VALVES. THEIR OCCURRENCE IS HIGHLY VARIABLE AMONG PATIENTS. IT IS GENERALLY BELIEVED THAT PATIENT BIOLOGICAL FACTORS AND/OR PREEXISTING MEDICAL CONDITIONS AND COMORBIDITIES PLAY MAJOR ROLES IN THE DEVELOPMENT OF BIOPROSTHETIC TISSUE CALCIFICATION AND/OR HOST FIBROTIC TISSUE OVERGROWTH. HOWEVER, THE UNDERLYING MECHANISMS ARE NOT COMPLETELY UNDERSTOOD. THE ATTACHMENT OF THE NATIVE MITRAL APPARATUS IN THE PRESENT CASE APPEARS LIKELY TO HAVE CONTRIBUTED TO THE HOST FIBROTIC TISSUE OVERGROWTH IN THIS PARTICULAR VALVE. HISTOLOGY DID NOT REVEAL ANY SPECIFIC INFORMATION TO EXPLAIN THE CALCIFICATION OBSERVED IN THIS PARTICULAR VALVE. PRESERVATION OR PARTIAL PRESERVATION OF THE NATIVE MITRAL VALVULAR TISSUE AND SUBVALVULAR APPARATUS WHENEVER POSSIBLE HAS BECOME A COMMON PRACTICE IN VALVE REPLACEMENTS. HOWEVER, IN SOME CASES, PRESERVING THE NATIVE VALVULAR TISSUE MAY RESULT IN INTERFERENCE WITH THE IMPLANTED BIOPROSTHETIC HEART VALVE, WHICH CAN REDUCE THE DEVICE¿S EFFECTIVENESS EITHER ACUTELY OR CHRONICALLY. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. IT IS LIKELY THAT PATIENT AND PROCEDURAL FACTORS MAY HAVE PLAYED A ROLE LEADING TO THIS EXPLANT. THE PROVIDED INFORMATION AND EDWARDS INVESTIGATION INDICATES NO DEVICE QUALITY DEFICIENCY THAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RECEIVED; HOWEVER, EVALUATION HAS NOT YET BEEN STARTED. DEVICE EVALUATION RESULTS AND EDWARDS' CONCLUSIONS WILL BE REPORTED ONCE AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO SALES BY HOSPITAL (B)(4) COORDINATOR THAT AN EDWARDS MITRAL PERICARDIAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 30 MONTHS DUE TO SEVERE MITRAL STENOSIS. ANOTHER EDWARDS MITRAL BIOPROSTHETIC VALVE MODEL 7300TFX WAS IMPLANTED IN ITS PLACE WITHOUT ANY COMPLICATIONS. THE PATIENT ALSO UNDERWENT A TRICUSPID VALVE REPAIR DURING THE SAME OPERATION. THE OPERATIVE REPORT INDICATES, " THE [SUBJECT] LEAFLETS WERE JUST COMPLETELY STUCK, COMPLETELY CALCIFIED. WE EXCISED THE OLD SUTURES AND REMOVED THE VALVE WITHOUT ANY DIFFICULTY. WE SIZED FOR A #29 PERICARDIAL VALVE AT THIS POINT. WE DID DEBRIDE SOME OF THE OLD LEAFLET TISSUE POSTERIORLY WHICH HAD CALCIFIED ALSO AT THIS POINT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84871 CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS HEART-VALVE, REPLACEMENT DYE EDWARDS LIFESCIENCES 6900PTFX R-08J2128

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| R LASIX 20 MG| SPIRONOLACTONE 100 MG| LORAZEPAM 1 MG| CALCITROL| PROTONIX 40 MG| URSO FORTE 500 MG| TOPROLOL 200 MG