BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3205573 · Received July 3, 2013

    Report

    Report Number
    2015691-2013-20534
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 10, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. PER THE INSTRUCTIONS FOR USE, VALVE REGURGITATION IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH BIOPROSTHETIC HEART VALVE AND THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. ACCORDING TO THE VALVE ACADEMIC RESEARCH CONSORTIUM (VARC), VALVE REGURGITATION CAN RESULT FROM A NUMBER OF FACTORS, INCLUDING, BUT NOT LIMITED TO PANNUS, CALCIFICATION, SUPPORT STRUCTURE DEFORMATION (OUT-OF-ROUND CONFIGURATION), ENDOCARDITIS, PROSTHETIC VALVE THROMBOSIS, AND NATIVE LEAFLET PROLAPSE IMPEDING PROSTHETIC LEAFLET MOTION. CINE AND ECHO IMAGES WERE SUBMITTED TO EDWARDS AND WERE REVIEWED BE THE MEDICAL DIRECTOR. THE FOLLOWING OBSERVATIONS AND IMPRESSIONS WERE MADE: OBSERVATIONS: TAVR DATE (B)(6) 2013 CINE. SEVERE AORTIC VALVE CALCIFICATION, SEVERE AORTIC ROOT CALCIFICATION, NO PORCELAIN AORTA, NO MAC. FAIR COAXIAL ALIGNMENT WITH LATERAL BIAS OF THE DELIVERY SYSTEM. FAIR IMAGE INTENSIFIER ANGLE (IIA). VALVE POSITIONED AND DEPLOYED 60:40 AORTIC. VENTILATION HELD DURING VALVE DEPLOYMENT. POSSIBLE PVC AT THE END OF THE PACING RUN WITHOUT SIGNIFICANT MOVEMENT OF THE VALVE FROM ITS INTENDED POSITION. POST VALVE DEPLOYMENT AORTOGRAM DEMONSTRATES AR ECHO (TEE). NO IMAGES OF VALVE DEPLOYMENT (ECHO PROBE PULLED BACK DURING DEPLOYMENT ON CINE) POST VALVE DEPLOYMENT, ON SHORT AXIS VIEW (SAX), THERE IS MILD PVL IN THE REGION OF THE FUNCTIONAL LCC. ON (B)(6) 2013 ECHO (TEE). NCC FUNCTIONING ON SAX. UNABLE TO ASSESS LCC / RCC. ON LAX THE NCC AND RCC APPEAR TO BE COAPTING WELL. THE LCC CANNOT BE VISUALIZED ON THE VIEWS PROVIDED. COLOR DOPPLER DEMONSTRATES A HIGH VELOCITY CENTRAL JET, AS WELL AS A MILD PVL SUBJACENT TO THE ANTERIOR MITRAL LEAFLET. DO NOT SEE EVIDENCE OF NATIVE LEAFLET OVERHANG ON LONG AXIS (LAX). ON LATER LAX, THERE IS PRESENCE OF AN ECHOGENIC LESION IN THE NON-CORONARY SOV THAT MAY BE CONSISTENT WITH BULKY CALCIFICATION OR THROMBUS. ALTHOUGH THIS MAY BEHAVE SIMILAR TO NATIVE LEAFLET OVERHANG IT APPEARS THAT THE NCC IS FUNCTIONING NORMALLY. LATER SAX DEMONSTRATES THE NCC AND RCC LEAFLETS APPEAR TO BE FUNCTIONING NORMALLY. THERE IS QUESTION IF THE LCC LEAFLET IS COAPTING NORMALLY. ON SAX COLOR DOPPLER MILD CAI IS DEMONSTRATED. IMPRESSIONS: NORMALLY FUNCTIONING NCC AND RCC WITH THE PRESENCE OF MILD CAI AND MILD PVL. THERE IS A QUESTION OF LCC LEAFLET DYSFUNCTION, POSSIBLY DUE TO BULKY CALCIFICATION OR THROMBUS. DR(B)(6) SUGGESTS CONSIDERATION OF 3 MONTHS OF WARFARIN PER THE LITERATURE. IN THIS CASE, A CLEAR CAUSE FOR THE CENTRAL AORTIC INSUFFICIENCY (CAI) CANNOT BE CONFIRMED; HOWEVER, IT APPEARS TO BE MILD, THERE DOES NOT APPEAR TO BE NATIVE LEAFLET OVERHANG, AND PER REPORT, THERE HAS BEEN NO PLAN FOR TREATMENT AT THIS TIME. THERE ARE ADDITIONAL PATIENT/ANATOMICAL FACTORS THAT MAY BE CONTRIBUTING TO THE PATIENT¿S SYMPTOMATOLOGY.

    Description of Event or Problem · 1

    AS REPORTED PER THE EDWARDS FIELD CLINICAL SPECIALIST (FCS), AT THE ONE MONTH FOLLOW UP VISIT, THE PATIENT WAS DISCOVERED TO BE IN HEART FAILURE, WITH MODERATE VALVULAR CENTRAL AORTIC INSUFFICIENCY (CAI) AND TRACE PARAVALVULAR LEAK (PVL). THE CAI IS CONSIDERED A NEW EVENT, AS THE CAI ON TEE POST PROCEDURE WAS TRACE TO NONE, AND THE ECHO AT DISCHARGE INDICATED THE CAI AS NONE. THE PATIENT IS STILL BEING EVALUATED, AND NO DIRECT PLAN TO TREAT HAS BEEN MADE YET. FOLLOW UP INFORMATION REVEALED THE PATIENT HAD MILD PVL AT THE RCC/LCC JUNCTION FROM NATIVE BULKY CALCIFICATION. THE VALVE LOOKED CIRCULAR ON TEE. INITIALLY POST IMPLANT, THERE WAS CONCERN THAT THERE WAS A STUCK LEAFLET, BUT THE VALVE FUNCTION IMPROVED WITH TIME AND ALSO AFTER EXCHANGING THE GUIDEWIRE FOR A JR4 CATHETER. THE FINAL AORTOGRAM LOOKED LIKE THERE WAS ONLY MILD LEAK. THE PATIENT WAS DISCHARGED FOUR DAYS POST PROCEDURE AND DID WELL INITIALLY. AFTER 2 WEEKS, THE PATIENT RETURNED WITH WORSENING CHF SYMPTOMS. STABILIZING ON PO DIURETICS, LASIX 40MG BID. PRE- TAVR, THE PATIENT HAD BEEN ON MAINTENANCE LASIX 40MG DAILY. EVERY TIME THEY WOULD TRY AND REDUCE DIURETICS, HE REDEVELOPED ORTHOPNEA AND PND. THE FOLLOW-UP TTE SHOWS MORE INTRAVALVULAR LEAK, AND THE SITE WAS WORRIED THERE WAS A LEAFLET ISSUE. THEY BELIEVE HIS CHF IS DUE TO AI WITH A STIFF SMALL LV CAVITY AND LVH. TEE THE PRIOR WEEK SUGGESTS THAT THERE MAY BE NATIVE LEAFLET OVERHANG BUT IT IS UNCLEAR AT THIS TIME. CLINICALLY, HE IS NYHA CLASS II ON HIGHER DIURETIC THERAPY BUT ISN'T GETTING THE "BOUNCE" HE SHOULD POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304992 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26A

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Other