BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

    MDR report key: 6248484 · Received January 13, 2017

    Report

    Report Number
    2015691-2017-00083
    Event Type
    Injury
    Date Received
    January 13, 2017
    Date of Event
    November 30, 2016
    Report Date
    December 13, 2016
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY NURSE CLARIFIED THAT THE ENDOGRAFT LIMBS WERE LONG AND THE XT VALVE WAS DEPLOYED ON THE PORTION OF THE ENDOGRAFT¿S RIGHT LIMB LOCATED IN THE DESCENDING AORTA. PER THE INSTRUCTIONS FOR USE (IFU) VALVE DEPLOYMENT IN UNINTENDED LOCATION IS A KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH THE TAVR PROCEDURE. THE TRANSFEMORAL TAVR PROCEDURE REQUIRES THE INSERTION OF LARGE BORE DEVICES. DIFFICULTY ADVANCING THE DELIVERY SYSTEM/CRIMPED VALVE THROUGH THE VASCULATURE MAY BE DUE TO ANATOMICAL AND/OR PROCEDURAL FACTORS, INCLUDING TORTUOUS VESSELS, PREVIOUSLY IMPLANTED STENTS AND/OR GRAFTS, WIRE BIAS, AND KINKED DELIVERY SYSTEM. IN MOST INSTANCES THIS RESOLVES WITH ROUTINE TROUBLESHOOTING MANEUVERS, WITH MINIMAL RISK TO THE PATIENT. THE THV PHYSICIAN TRAINING MANUALS INSTRUCT ON PROCEDURAL CONSIDERATIONS FOR SHEATH INSERTION WITH REGARDS TO PROPER SCREENING CRITICAL TO REDUCING VASCULAR COMPLICATIONS. THE TRAINING MANUAL INSTRUCTS THE OPERATOR ON PROPER SHEATH INSERTION AND WITHDRAWAL TECHNIQUES, INCLUDING PRE-DILATING THE VESSEL WITH THE EDWARDS DILATORS, AS NEEDED. IT ALSO NOTES THAT CALCIFICATION MAY REDUCE LUMEN DIAMETER AND LIMIT OR PREVENT TRANSFEMORAL PASSAGE OF THE DEVICES. IN THIS CASE, PER THE OPERATIVE REPORT THE OPERATOR WAS UNABLE TO SAFELY MOVE THE DEVICES BECAUSE THE CRIMPED VALVE GOT STUCK WITHIN THE ENDOGRAFT. IT WAS DECIDED TO DEPLOY THE XT VALVE IN THE AORTA TO PREVENT INJURING THE VESSEL. THERE WAS NO ALLEGATION OR INDICATION OF A DEVICE MALFUNCTION. THE IFU 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 PREVENTATIVE ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS EVENT IS ONGOING.

    Description of Event or Problem · 1

    A TRANSFEMORAL TAVR PROCEDURE FOR A 26MM SAPIEN 3 VALVE WAS ABORTED DUE TO ¿VALVE IMPINGEMENT WITHIN THE ZENITH GRAFT¿. ACCORDING TO THE OPERATIVE REPORT, THE PATIENT HAS HISTORY OF HAVING AN AORTO-FEMORAL PERCUTANEOUS GRAFT PLACEMENT WITH A COOK ZENITH AORTO-ILIAC GRAFT. WHILE TRYING TO ADVANCE THE 26MM S3/14 FR ESHEATH, THE VALVE GOT STUCK WITHIN THE AORTO-ILIAC GRAFT. THE PHYSICIAN WAS UNABLE TO MOVE THE VALVE WITHOUT CAUSING INJURY AND IT WAS DECIDED TO IMPLANT THE VALVE IN THE RIGHT LIMB OF THE GRAFT WITH AN 18MM BALLOON VALVULOPLASTY CATHETER. ONCE THIS WAS PERFORMED THEY REMOVED THE DELIVERY SYSTEM AND USED PERCLOSE DEVICE SUTURES TO CLOSE THE FEMORAL ARTERY. A LEFT ANTERIOR THORACOTOMY WAS THEN MADE, AND A TRANSAPICAL TAVR PROCEDURE WAS SUCCESSFULLY PERFORMED WITH A 26MM SAPIEN XT VALVE IN THE AORTIC POSITION. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO THE RECOVERY UNIT IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32951 EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9600TFX26A

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other