BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2962806 · Received February 15, 2013

    Report

    Report Number
    2015691-2013-19288
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 22, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE HOSPITAL INDICATING THE PATIENT EXPIRED FROM LOW CARDIAC OUTPUT AND THE SAPIEN VALVE DID NOT HAVE ANY NEGATIVE IMPACT ON HER OUTCOME. THE CIRCUMFLEX (CX) ARTERY OCCLUSION WAS REPORTED TO BE EMBOLIC. CINE AND ECHO IMAGES WERE SUBMITTED TO EDWARDS LIFESCIENCES FOR REVIEW. THE OBSERVATIONS ARE AS FOLLOWS: THE PATIENT HAS MODERATE AORTIC VALVE CALCIFICATION, SEVERE AORTIC ROOT CALCIFICATION, NO PORCELAIN AORTA, AND MITRAL ANNULAR CALCIFICATION (MAC). BAV X1 DEMONSTRATED. GOOD COAXIAL ALIGNMENT, FAIR IMAGE INTENSIFIER ANGLE (IIA) WAS OBSERVED. THE VALVE WAS POSITIONED 65:35 AORTIC AND DEPLOYED 65:35. THERE WAS NO MOVEMENT NOTED DURING DEPLOYMENT. POST DEPLOYMENT AORTOGRAM DEMONSTRATED AORTIC REGURGITATION (AR). THE VALVE POSITIONING WAS TOO AORTIC BUT CORONARY FILLING IS TIMI3 IMMEDIATELY POST VALVE DEPLOYMENT. POSSIBLE THROMBUS IN THE LEFT MAIN AND AT THE ORIGINS OF THE LAD AND CIRCUMFLEX; AND OBSTRUCTION IN A PROXIMAL OM BRANCH WAS VISIBLE WHICH WAS TREATED WITH PCI. ON TEE IMAGING, NO OBLITERATION OF SOV (8.1MM) WAS OBSERVED. THE IMPRESSIONS OF THE IMAGING ARE AS FOLLOWS: THE FINAL SAPIEN POSITION WAS TOO AORTIC HOWEVER; PRESENCE OF SATISFACTORY CORONARY PERFUSION WITH OBSTRUCTION OF A LARGE OM BRANCH WAS PRESENT. ABSENCE OF BULKY LEAFLET CALCIFICATION, OBLITERATION OF SOV, OR SIGNIFICANT VALVE OVER-SIZING MAKE THE LIKELIHOOD OF SAPIEN MEDIATED CORONARY OBSTRUCTION LESS LIKELY. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), COMPLICATIONS ASSOCIATED WITH THE USE OF BIOPROSTHETIC HEART VALVES INCLUDE POTENTIAL CORONARY OBSTRUCTION DUE TO SEVERE BULKY CALCIFICATION. THE IFU INSTRUCTS THE OPERATOR TO EVALUATE THE HEIGHT BETWEEN THE INFERIOR ASPECT OF THE ANNULUS AND THE INFERIOR ASPECTS OF THE LOWEST CORONARY OSTIUM FOR SUBSEQUENT PROSTHETIC AORTIC VALVE IMPLANTATION. IN ADDITION POST TAVR THE OPERATOR IS INSTRUCTED TO PERFORM A SUPRA-AORTIC ANGIOGRAM TO EVALUATE DEVICE PERFORMANCE AND CORONARY PATENCY. IN THIS CASE, THE CAUSE OF THE PATIENT'S DEATH WAS REPORTEDLY DUE TO 'BEING ON PUMP FOR 8 HOURS THE PATIENT HAD MULTI SYSTEM SHUT DOWN. SHE BEGAN TO SWELL AND THEY HAD TO REOPEN HER CHEST BECAUSE THE SWELLING WAS CAUSING TAMPONADE TO THE HEART. THEY FELT THAT SHE PASSED FROM THE POOR HEALTH SHE WAS IN AND FROM THE LENGTH OF THE PROCEDURE.' PER THE IMAGING REVIEW, THE ABSENCE OF BULKY LEAFLET CALCIFICATION, OBLITERATION OF SOV, OR SIGNIFICANT VALVE OVER-SIZING MAKE THE LIKELIHOOD OF SAPIEN MEDIATED CORONARY OBSTRUCTION UNLIKELY. IT APPEARS THAT THE THROMBUS ORIGINALLY REPORTED, AND NOTED IN THE RETURNED IMAGES, APPEARS TO HAVE CAUSED THE CORONARY ARTERY OBSTRUCTION. SINCE THERE IS NO ALLEGATION OF DEVICE MALFUNCTION, OR LABELING ISSUES, AND THE DEVICE REMAINS IMPLANTED, NO FURTHER INVESTIGATIONAL ACTIVITIES WILL BE PERFORMED. THE IFU AND EDWARDS THV PATIENT SCREENING AND TRAINING MANUALS HAVE BEEN REVIEWED AND NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. NO CORRECTIVE OR PREVENTIVE ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    THIS PATIENT WAS NOTED TO HAVE SEVERE CALCIFICATION OF THE NATIVE VALVE AND LEAFLETS AND SEVERE MITRAL ANNULAR CALCIFICATION. AT THE TIME OF THE TAVR PROCEDURE, PRIOR TO DEPLOYMENT, THE SAPIEN VALVE WAS INTENTIONALLY POSITIONED HIGHER IN THE AORTA IN A 70:30 POSITION AND IT WAS NOTED THAT GOOD RESULT WAS OBTAINED. INVESTIGATION FOR THE ROOT CAUSE IS IN PROCESS.

    Description of Event or Problem · 1

    AS REPORTED VIA THE EDWARDS CLINICAL SPECIALIST, DURING A TRANSAPICAL TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE, POST DEPLOYMENT OF THE EDWARDS SAPIEN VALVE, THE PATIENT HAD ST SEGMENT ELEVATION. AN EJECTION OF THE CORONARY ARTERIES REVEALED THERE WAS A BLOCKAGE OF THE LARGE 2ND OM BRANCH OF THE CIRCUMFLEX ARTERY. IT WAS THOUGHT TO BE THROMBUS AND A FETCH ASPIRATION WAS USED TO REMOVE THROMBUS. A BARE METAL STENT BMS WAS PLACED WITH GOOD RESULT. AN IABP WAS PLACED AND THE PATIENT WAS STABLE AND LEFT THE OR. ACCORDING TO THE CASE SUMMARY, THIS (B)(6) FEMALE PATIENT WAS PRESENTED WITH BOTH AORTIC AND MITRAL VALVE STENOSIS. SHE WAS A CANCER SURVIVOR AND HAD RECEIVED RADIATION TREATMENT AND TOTAL MASTECTOMY OF THE RIGHT BREAST SOME YEARS AGO. THE AORTIC ARCH WAS EXTREMELY CALCIFIED THEREFOR SHE COULD NOT UNDERGO AORTIC VALVE REPAIR. IT WAS THOUGHT THAT WITHOUT REPAIRING THE MITRAL VALVE FIRST THE PATIENT WOULD NOT IMPROVE. IN A PLANNED OPEN HEART THE MITRAL VALVE WAS REMOVED AND REPLACED WITH AN EDWARDS 25MM MITRAL VALVE. THIS WAS A COMPLEX OPERATION THAT TOOK OVER 6 HOURS. AFTER THE MITRAL VALVE WAS REPLACED AN EDWARDS 26MM SAPIEN VALVE WAS PLACED 70/30 AORTIC. PLACEMENT OF VALVE WAS INTENTIONALLY HIGHER IN THE AORTA THAN NORMAL TO AVOID THE NEWLY PLACED MITRAL VALVE. A GOOD RESULT WAS OBTAINED. AFTER THE PLACEMENT AND CLOSURE IT WAS NOTICED THAT THERE WAS ST ELEVATION AND A THROMBUS WAS DISCOVERED IN THE LARGE 2ND OM BRANCH OF THE CIRCUMFLEX ARTERY. IT WAS REMOVED AND A BARE METAL STENT WAS PLACED WITH GOOD RESULT AND AN INTRA AORTIC BALLOON PUMP WAS PLACED AND PATIENT LEFT THE OR. THIS PATIENT EXPIRED 2 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67006 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death| R