BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS BIOPROSTHESIS

    MDR report key: 2120880 · Received June 11, 2011

    Report

    Report Number
    2015691-2011-15703
    Event Type
    Injury
    Date Received
    June 11, 2011
    Date of Event
    April 4, 2011
    Report Date
    May 13, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P870056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. DESPITE MULTIPLE FOLLOW-UPS WITH THE HEALTHCARE PROVIDER, NO ADDITIONAL INFORMATION WAS PROVIDED SUCH AS THE REASON FOR EXPLANT, PATIENT CONDITION, AND DEVICE STATUS FOR RETURN; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED INTO THE ROOT CAUSE OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: AS RECEIVED, THE RETURNED VALVE EXHIBITS HEAVY THROMBUS-LIKE DEPOSITS IN THE BELLY REGION OF THE RIGHT CORONARY LEAFLET AT THE OUTFLOW ASPECT. MINIMAL TO MODERATE DEPOSITS ARE ALSO NOTED IN THE BELLY REGION OF THE NON-CORONARY LEAFLET. THE THROMBUS LIKE DEPOSITS RESTRICTED MOBILITY IN THE LEAFLETS AND LED TO STENOSIS. MOREOVER, MINIMAL HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE AT BOTH ASPECTS AND INTO THE ORIFICE AT THE GREATEST POINT BY APPROXIMATELY 2MM AT THE TISSUE INFLOW, AND 4MM AT THE TISSUE OUTFLOW. HOST TISSUE IS MINIMAL AT THE STENT OUTFLOW. NO INCONSISTENCIES DETECTED IN THE X-RAY AS THE WIREFORM IS INTACT. ADDITIONAL MANUFACTURER NARRATIVE: THE INVESTIGATION INDICATES THAT THE THROMBUS FORMATION AND STENOSIS OF THIS VALVE IS MORE LIKELY RELATED TO PATIENT'S CO-MORBIDITIES. THROMBOSIS HAS AN EXTREMELY LOW INCIDENCE RATE IN BIOPROSTHETIC HEART VALVES. THE MECHANISM OF THROMBOTIC DEPOSITION ON BIOPROSTHETIC HEART VALVES IS STILL NOT FULLY UNDERSTOOD; HOWEVER, PATIENTS WITH HISTORY OF ATRIAL FIBRILLATION/FLUTTER ARE TYPICALLY AT A HIGH RISK OF THROMBUS FORMATION. THERE HAS BEEN NO INFORMATION TO SUGGEST A DEVICE QUALITY DEFICIENCY THAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    OPERATIVE REPORT AND DISCHARGE SUMMARY WERE PROVIDED INDICATING THE VALVE WAS EXPLANTED DUE TO SEVERE MITRAL STENOSIS. FINDINGS INDICATE TEE SHOWED THROMBUS IN THE LA ADJACENT TO THE MITRAL VALVE, SEVERE MS, SEVERE TR, DIALTED LV, LVEF 20%, MILD AI. IT WAS NOTED THAT THE SUBJECT MITRAL PORCINE VALVE HAD DEGENERATIVE CHANGES INVOLVING ON OF THE LEAFLETS. THE SEWING RING WAS WELL HEALED INTO THE ANNULUS WITH NO EVIDENCE OF INFECTION OR PARAVALVULAR LEAK. THE EXCISED VALVE WAS REPLACED WITH A #27 CARPENTIER EDWARDS PERICARDIAL VALVE.

    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 LEARNED THAT THE EDWARDS' VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 35 MONTHS. THE REASON FOR EXPLANTING THE DEVICE WAS NOT REPORTED, AND NO FURTHER DETAILS WERE RECEIVED BY THE HEALTHCARE PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6625 6F1009

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R METOPROTOL TARTRATE 100MG TWICE A DAY| SPIRONOLACTONE 25MG ONCE A DAY| DIGOXIN 125 MCG ONCE A DAY| AMBIEN 10MG ONCE A DAY| PROTONIX 40MG ONCE A DAY| DIOVAN 80 MG ONCE A DAY