BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS

    MDR report key: 2964364 · Received February 15, 2013

    Report

    Report Number
    2015691-2013-19299
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    December 18, 2012
    Report Date
    January 17, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P870077
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A RESPONSE WAS RECEIVED FROM THE HEALTHCARE PROVIDER INDICATING THAT THIS DEVICE WAS EXPLANTED DUE TO MITRAL REGURGITATION (MR), SECONDARY TO A FLAILED LEAFLET. ACCORDING TO THE OP REPORT, ECHO REVEALED SIGNIFICANT LEAK INVOLVING THE MITRAL PROSTHESIS WITH PROBABLY TORN LEAFLET. THERE WAS SEVERE MR AND MODERATELY SEVERE TRICUSPID REGURGITATION. THEREFORE, THE PATIENT WAS REFERRED FOR REDO-MITRAL VALVE REPLACEMENT AND TRICUSPID VALVE REPAIR. UPON INSPECTION OF THE MITRAL VALVE, IT WAS NOTED TO BE WELL HEALED. ONE OF THE THREE CUSPS WAS COMPLETELY FLAIL. THE DEVICE WAS REPLACED WITH A NEW EDWARDS PROSTHETIC VALVE. TRANSESOPHAGEAL ECHOCARDIOGRAM AT COMPLETION OF THE PROCEDURE SHOWED THE NEW PROSTHESIS FUNCTIONING NICELY. THE PATIENT WAS REPORTED TO HAVE TOLERATED THE PROCEDURE SATISFACTORILY. UNFORTUNATELY, THE EXPLANTED DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS; THEREFORE, THE REPORTED FINDINGS COULD NOT BE CONFIRMED. MR IN BIOPROSTHETIC HEART VALVES OCCURS WHEN THE VALVE DOES NOT CLOSE PROPERLY IN SYSTOLIC PHASE, WHICH RESULTS IN RETROGRADE FLOW OF BLOOD INTO THE LEFT ATRIUM. TRIVIAL/TRACE TO MILD AMOUNTS OF MR ARE NOT UNUSUAL IN BIOPROSTHETIC VALVES IN THE IMMEDIATE POST-OPERATIVE SETTING, AND IS USUALLY TOLERATED BY PATIENTS. HOWEVER, IF THE REGURGITATION WORSENS OR BECOMES SYMPTOMATIC, REOPERATION MAY BE NECESSARY. THE TYPE AND CAUSE OF REGURGITATION VARIES DEPENDING UPON MULTIPLE FACTORS. REGURGITATION WHICH DEVELOPS PROGRESSIVELY OVER TIME CAN BE DUE TO A NUMBER OF ISSUES INCLUDING PATIENT RELATED FACTORS OR STRUCTURAL VALVE DETERIORATION (SVD). IN THIS CASE, IT WAS REPORTED THAT THERE WAS LEAFLET FLAIL, WHICH IS A COMMON CHARACTERISTIC OF SVD. ALTHOUGH THE ROOT CAUSE OF THIS EVENT CANNOT BE CONCLUSIVELY DETERMINED, IT APPEARS THAT THIS WAS LIKELY THE CAUSE OF THE REGURGITATION. ADVANCES IN VALVE DESIGN AND BIOPROSTHETIC MATERIAL HAVE BEEN MADE WITH THE INTENTION OF REDUCING PERIVALVULAR OR CENTRAL LEAKS BY PROVIDING MORE EFFICIENT HEMODYNAMICS AND LONGER TISSUE DURABILITY. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. DESPITE REPEATED ATTEMPTS TO RECEIVE FURTHER INFORMATION REGARDING THE DEVICE AND EVENT, NO ADDITIONAL INFORMATION OR SAMPLE FOR EVALUATION WAS RECEIVED. THEREFORE, THE ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED. THERE HAVE NOT BEEN ANY ALLEGATIONS OF A MALFUNCTION OR DEFICIENCY RELATED TO THE EXPLANTED VALVE. CONTINUED ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL DETAILS REGARDING THIS CASE. A SUPPLEMENTAL MDR WILL BE SUBMITTED IN THE EVENT ANY NEW INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT". THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE. IN THIS CASE, IT WAS REPORTED THAT THE VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 4 YEARS, 8 MONTHS. THE REASON FOR EXPLANT IS UNKNOWN. DESPITE REPEATED ATTEMPTS TO RECEIVE FURTHER INFORMATION REGARDING THE DEVICE AND EVENT, NO ADDITIONAL INFORMATION OR SAMPLE FOR EVALUATION WAS RECEIVED. THERE HAVE NOT BEEN ANY ALLEGATIONS OF A MALFUNCTION OR DEFICIENCY RELATED TO THE EXPLANTED VALVE. THE DEVICE WAS REPLACED WITH ANOTHER EDWARDS VALVE. NO OTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68209 CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6625ESRLP

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R