BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARPENTIER-EDWARDS® PERIMOUNT® PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 4854161 · Received June 18, 2015

    Report

    Report Number
    2015691-2015-01453
    Event Type
    Malfunction
    Date Received
    June 18, 2015
    Date of Event
    May 21, 2015
    Report Date
    May 21, 2015
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THICKENED AND STENOTIC. METHOD: DEVICE NOT RECEIVED. ADDITIONAL MANUFACTURER NARRATIVE: THE DHR REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. THIS DEVICE IS REPORTEDLY "STENOTIC" WITH THICKENED AND STIFF LEAFLETS. HOWEVER, THERE IS NO AVAILABLE INFORMATION TO DETERMINE THE ACTUAL CONDITION OF THE VALVE IN SITU AND THERE ARE NO PATIENT RECORDS AVAILABLE. THE INITIAL COMMENTS MADE BY THE HOSPITAL CONSULTING SURGEON CANNOT BE CONFIRMED AS THE IMPLANT PROCEDURE WAS CONDUCTED AT A DIFFERENT FACILITY. THEREFORE, THE STATEMENT REGARDING THE WASHING PROTOCOL USED BY THE SCRUB NURSES CANNOT BE VERIFIED. ALTHOUGH BIOPROSTHETIC VALVES HAVE BEEN PROVEN TO HAVE EXCELLENT LONG TERM DURABILITY, FAILURE DOES OCCUR IN A SMALL NUMBER OF VALVES. REPLACEMENT OF A BIOPROSTHETIC VALVE OVER TIME IS MORE LIKELY DUE TO STRUCTURAL VALVE DETERIORATION (SVD) WHICH OCCURS AS A RESULT OF STENOSIS (FROM CALCIFICATION OR HOST TISSUE OVERGROWTH), FIBROSIS OR NON-CALCIFIC DEGENERATION. IN THIS CASE, THE CAUSE OF THE REPORTED STENOSIS IS MOST LIKELY DUE TO PATIENT RELATED FACTORS. HOWEVER, MINIMAL INFORMATION REGARDING THIS VALVE WAS RECEIVED AND SUBSEQUENT ATTEMPTS TO GET ADDITIONAL INFORMATION REGARDING THE CONDITION OF THE DEVICE, CONTRIBUTING FACTORS, OR PATIENT HISTORY HAVE BEEN UNSUCCESSFUL. THERE ARE NO PLANS TO EXPLANT THIS VALVE; THEREFORE, WE ARE UNABLE TO CONFIRM THE CLINICAL COMMENTS MADE OR TO DETERMINE ROOT CAUSE FOR THE CONDITION OF THIS DEVICE. THE IFU WAS REVIEWED AND NO INADEQUACIES WERE IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED. NO CORRECTIVE OR PREVENTATIVE ACTIONS APPLY TO THIS CASE.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION THAT A 27MM MITRAL PERICARDIAL VALVE, IMPLANTED FOR APPROXIMATELY THREE (3) YEARS AND ELEVEN (11) MONTHS, IS SHOWING SIGNS OF STENOSIS. THIS PATIENT RECENTLY PRESENTED WITH PULMONARY EDEMA. REPORTEDLY, THIS PATIENT HAS BEEN DIAGNOSED WITH PROSTHETIC MITRAL STENOSIS, REQUIRING RE-DO SURGERY. HOWEVER, THE PATIENT IS CONSIDERED TOO FRAIL FOR RE-DO SURGERY AND WILL LIKELY UNDERGO TRANSCATHETER VALVE INTERVENTION. THE PATIENT IS CURRENTLY UNDER MONITOR AT ANOTHER HOSPITAL. A VERBAL REPORT OF THE ECHO RESULTS IS OF PROSTHETIC STENOSIS FROM NON-PLIABLE LEAFLETS. THE CONSULTING SURGEON SUSPECTS THIS IS DUE TO POOR WASHING (OF THE PERICARDIAL VALVE) BY THE SCRUB NURSES (AT TIME OF IMPLANT). THIS PATIENT HAS MIXED MITRAL VALVE DISEASE WITH PULMONARY HYPERTENSION. DUE TO A HISTORY OF HAEMORRHAGIC CYSTITIS, SHE NEEDED A BIOLOGICAL VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397000 CARPENTIER-EDWARDS® PERIMOUNT® PLUS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900P

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR