BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 1903877 · Received November 20, 2010

    Report

    Report Number
    2015691-2010-14407
    Event Type
    Injury
    Date Received
    November 20, 2010
    Date of Event
    October 21, 2010
    Report Date
    October 21, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER REPORTED AGE OF DEVICE AS 7 YEARS. HOWEVER, THE ACTUAL AGE OF THE DEVICE AT EXPLANT WAS 92 MONTHS. HOWEVER, THE DEVICE CODES REPORTED BY THE CUSTOMER, (B)(4), WERE NOT USED AS THEY ARE NOT AVAILABLE. THE DEVICE (B)(4) WERE ENTERED ARE BASED ON THE CUSTOMERS REPORT OF STENOSIS AND PERIVALVULAR LEAK. EVALUATION SUMMARY: HEAVY HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE INFLOW AND INTO THE ORIFICE AT THE GREATEST POINT OF APPROXIMATELY 6MM. MINIMAL TO MODERATE HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE OUTFLOW AND INTO THE ORIFICE BY APPROXIMATELY 3-4MM. HOST TISSUE OVERGROWTH MOST LIKELY LED TO STENOSIS. HOST TISSUE OVERGROWTH IS MODERATE AT THE STENT INFLOW AND THE STENT OUTFLOW. CALCIFICATION IS MINIMAL IN THE CUSP AREA OF LEAFLET 1. THE X-RAY DEMONSTRATES CALCIFICATION. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCES. 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. PANNUS OCCURRING PRIOR TO 12 MONTHS IS RARE AND SUGGESTS PATIENT FACTORS MAY HAVE PLAYED A SIGNIFICANT ROLE. 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

    Description of Event or Problem · 1

    IT WAS REPORTED BY OUR SALES STAFF THAT HE RECEIVED A CALL FROM THE HOSPITAL CONTACT REGARDING AN EXPLANT, NO ADDITIONAL INFORMATION WAS GIVEN OTHER THAN A RETURN KIT WAS REQUESTED. ON 17-NOV-2010, A COPY OF A VOLUNTARY MEDWATCH UF/IMPORTER REPORT# (B)(4) WAS RECEIVED. IT REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR A REDO STERNOTOMY, EXPLANTATION OF A 21MM EDWARDS BOVINE PERICARDIAL TISSUE HEART VALVE, AORTIC VALVE REPLACEMENT WITH A 23MM SORIN MITROFLOW BOVINE PERICARDIAL TISSUE HEART VALVE, AND TRICUSPID VALVE REPAIR WITH A 32MM MC3 ANNULOPLASTY BAND SECONDARY TO PROSTHETIC VALVE STENOSIS WITH PERIVALVULAR REGURGITATION AND CONGESTIVE HEART FAILURE CLASS 3. THIS AORTIC VALVE HAD BEEN PLACED IN (B)(6) 2003 BY DR (B)(6).

    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 3A0178

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention