BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE

    MDR report key: 4251372 · Received November 14, 2014

    Report

    Report Number
    2015691-2014-02701
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 20, 2014
    Report Date
    October 20, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT APPEARS THE CAUSE OF THE MIGRATION OF THE 23MM SAPIEN XT MAY HAVE BEEN DUE TO VALVE UNDER-SIZING. THE VALVE LATER EMBOLIZED DUE TO A PROCEDURAL COMPLICATION. SUBSEQUENTLY, A VALVE IN VALVE PROCEDURE WAS PERFORMED WITH TWO 26MM XT VALVES, HOWEVER, NO FURTHER INFORMATION WAS PROVIDED. THE REASON FOR DEPLOYMENT OF THE 2ND SAPIEN XT IS UNKNOWN. AT THIS TIME THE SAPIEN XT VALVE IS NOT INDICATED FOR USE IN THE MITRAL POSITION OR WITHIN A PRE-EXISTING THV VALVE, THEREFORE THE IFU AND TRAINING MANUALS DO NOT PROVIDE INSTRUCTIONS ON THE STEPS FOR POSITIONING AND DEPLOYMENT OF THE VALVE WITHIN A PROSTHETIC VALVE IN THIS POSITION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PROVIDED THROUGH A WRITTEN ARTICLE INDICATED THAT THE 26MM SAPIEN XT WAS DEPLOYED THROUGH THE LEFT ATRIUM INTO A PREEXISTING CE VALVE. THE DECISION WAS MADE TO PERFORM THE PROCEDURE ON CARDIOPULMONARY BYPASS WITHOUT ARRESTING THE HEART. AFTER DEPLOYMENT, THE 26MM SAPIEN XT MIGRATED TOWARDS THE LEFT VENTRICLE. THE VALVE COULD NOT BE REPOSITIONED MANUALLY DUE TO ACCESSIBILITY ISSUES. AN ADDITIONAL 26MM SAPIEN XT VALVE WAS THEN PLACED, BRIDGING THE CE VALVE AND THE FIRST-PLACED-26MM SAPIEN XT VALVE. THE SURGEON ADDED 4-0 PROLENE SUTURES TO TACK BOTH 26MM XT VALVES IN PLACE TO THE RING OF THE CE. THE PATIENT WAS THEN WEANED FROM BYPASS. THE PATIENT WAS DISCHARGED ON POST-OPERATIVE DAY 13 TO A SKILLED NURSING FACILITY WITH TRIVIAL MITRAL REGURGITATION, A PEAK GRADIENT OF 17MMH AND MEAN GRADIENT OF 6MMHG RESPECTIVELY. ARTICLE BIBLIOGRAPHY: STEPHANIE, MICK. L, MD, ERIC E. ROSELLI, MD, SAMIR KAPADIA, MD, E. MURAT TUZCU, MD, AMAR KRISHNASWAMY, MD, AND LARS G. SVENSSON, MD, PHD (2016). POSTOPERATIVE MIGRATION OF AN EDWARDS-SAPIEN XT MITRAL VALVE-IN-VALVE TREATED WITH DIRECT VISION IMPLANTATION DURING BEATING-HEART BYPASS. THE ANNALS OF THORACIC SURGERY, 101, ISSUE 3, 1182-1185. REF. RELATED MFG REPORT NUMBER 2015691-2014-02700.

    Description of Event or Problem · 1

    POST DEPLOYMENT OF A SAPIEN XT VALVE IN A PRE-EXISTING SURGICAL VALVE, A SECOND SAPIEN XT WAS DEPLOYED WITHIN THE FIRST SAPIEN XT. INITIALLY A 23MM SAPIEN XT WAS DEPLOYED IN A PRE-EXISTING SURGICAL MITRAL VALVE. 26 DAYS POST IMPLANT, ECHO SHOWED THE XT VALVE HAD MIGRATED ATRIAL. THE DECISION WAS MADE TO BRING THE PATIENT BACK FOR A THV IN THV IN BIOPROSTHETIC VALVE PROCEDURE. DUE TO THE THV VALVE MIGRATION ATRIAL POST-PROCEDURE, THE PHYSICIANS OPTED TO DEPLOY A 26MM SAPIEN XT VALVE INTO THE 23MM SAPIEN XT VALVE. THERE WAS CONCERN IF THEY APPROACHED THE VALVE FROM A TRANSAPICAL APPROACH, THE 23MM SAPIEN XT COULD EMBOLIZE; THEREFORE THEY DECIDED TO APPROACH THROUGH THE LEFT ATRIUM. A RIGHT SIDED THORACTOMY WAS PERFORMED. AS THE CARDIOLOGIST WAS ATTEMPTING TO GET THE WIRE THROUGH (BOTH) THE 23MM SAPIEN XT VALVE AND THE SURGICAL VALVE, THE WIRE ACTUALLY WENT IN THROUGH THE SPACE BETWEEN THE TWO VALVES AND BACK UP THROUGH THE 23MM SAPIEN XT RETROGRADE, CAUSING THE SAPIEN XT VALVE TO EMBOLIZE INTO THE LA. THE DECISION WAS MADE TO KEEP THE 23MM SAPIEN XT ON THAT WIRE, AND APPROACH THE SURGICAL VALVE WITH A NEW WIRE TO ATTEMPT TO DEPLOY A NEW 26MM SAPIEN XT VALVE IN THE SURGICAL VALVE. DUE TO THE ANATOMY AND THE LOCATION OF THE APPROACH IN THE LA, THE PHYSICIANS HAD GREAT DIFFICULTY IN ALIGNING THE ASCENDRA+ SYSTEM AND GETTING IT TO CROSS THE SURGICAL VALVE. MUCH TIME WAS SPENT ATTEMPTING TO CROSS. THE TEAM DECIDED TO REMOVE THE 26MM SAPIEN XT VALVE AND RE-APPROACH WITHOUT A SHEATH. AS THE DELIVERY SYSTEM WAS BEING REMOVED, THE XT VALVE BECAME STUCK IN THE HEMOSTASIS PORT OF THE SHEATH, THUS IT WAS NEVER DEPLOYED IN THE PATIENT. ULTIMATELY, THE DECISION WAS MADE TO PLACE THE PATIENT ON BYPASS, REMOVE THE EMBOLIZED 23MM SAPIEN XT VALVE, AND OPEN THE LA FOR DIRECT VISUALIZATION AND APPROACH. A SECOND 26MM SAPIEN XT WAS PREPPED WHILE THE LEFT ATRIUM WAS OPENED. THEN, UNDER DIRECT VISUALIZATION, THE 26MM SAPIEN XT WAS DEPLOYED INTO THE SURGICAL VALVE (NO FLUROSCOPY USED). THE VALVE WAS POST DILATED WITH 2 EXTRA CC'S OF VOLUME. THE DECISION WAS THEN MADE TO DEPLOY A SECOND 26MM SAPIEN XT VALVE INTO THE PREVIOUS 26MM SAPIEN XT VALVE (INSIDE THE SURGICAL VALVE). THE SECOND 26MM SAPIEN XT VALVE WAS PREPPED IN STANDARD FASHION AND DEPLOYED, AGAIN UNDER DIRECT VISUALIZATION AND NO FLUROSCOPY. THE VALVE WAS POST DILATED WITH 2 EXTRA CC'S OF VOLUME. THE PATIENT LEFT THE ROOM WITH TRACE PVL AND IN STABLE CONDITION. NOTE: THIS EVENT PERTAINS TO THE FIRST 26MM SAPIEN XT VALVE THAT WAS IMPLANTED. REFERENCE MFGR REPORT # 2015691-2014-02700.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736832 EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9300TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention