BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS NOVAFLEX+ DELIVERY SYSTEM

    MDR report key: 4235907 · Received November 7, 2014

    Report

    Report Number
    2015691-2014-02628
    Event Type
    Injury
    Date Received
    November 7, 2014
    Date of Event
    October 15, 2014
    Report Date
    October 15, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE (IFU) CARDIOVASCULAR INJURY, SUCH AS PERFORATION OR DAMAGE (DISSECTION) OF VESSELS, VENTRICLE, MYOCARDIUM OR VALVULAR STRUCTURES, IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE TAVR PROCEDURE. ASCENDING AORTIC DISSECTION MAY OCCUR WHEN MULTIPLE ATTEMPTS ARE MADE TO CROSS THE STENOTIC NATIVE VALVE, AND/OR WHEN EXCESSIVE FORCE IS USED. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE SAPIEN XT TRANSCATHETER HEART VALVE (THV). THE THV TRAINING MANUALS PROVIDE GUIDANCE TO FACILITATE SAFE CROSSING OF THE NATIVE VALVE, INCLUDING CAMERA PROJECTIONS, HANDLING DURING ADVANCEMENT, AND TROUBLESHOOTING TECHNIQUES IF DIFFICULTY IS ENCOUNTERED. AS STATED, EXCESSIVE FORCE SHOULD NOT BE USED WHEN THE DEVICE HAS DIFFICULTY CROSSING THE STENOTIC VALVE. ADDING TENSION TO THE WIRE, PULLING BACK THE SYSTEM TO RE-ORIENT THE VALVE, AS NEEDED, AND TORQUING OF THE FLEX CATHETER MAY BE HELPFUL IN SOLVING THE PROBLEM. IN THIS CASE, THE PATIENT¿S PRE-EXISTING THORACIC ANEURYSM, EXTREMELY TORTUOUS AORTA, AND SEVERE AORTIC ROOT CALCIFICATION LIKELY CONTRIBUTED TO THIS EVENT. 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. THIS IS ONE OF TWO MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. PLEASE REFERENCE RELATED MANUFACTURER REPORT NO: 2015691-2014-02605.

    Description of Event or Problem · 1

    DURING THE TRANSFEMORAL (TF) TAVR PROCEDURE, A THORACIC ANEURYSM RUPTURED AND WAS SURGICALLY REPAIRED. FOLLOWING BALLOON AORTIC VALVULOPLASTY (BAV), THE NOVAFLEX+ (NF+) DELIVERY SYSTEM (DS) WAS INSERTED AND ADVANCED INTO THE EXPANDABLE SHEATH (ESHEATH). WHEN THE DS WAS ABOUT 2 INCHES ABOVE THE TIP OF THE ESHEATH, THE PATIENT BECAME HYPOTENSIVE. IT WAS OBSERVED THAT A 4CM THORACIC ANEURYSM RUPTURED AT THE LEVEL OF THE TRANSVERSE AORTA. THE TF PROCEDURE WAS ABORTED PRIOR TO THE DEPLOYMENT OF THE SAPIEN XT VALVE. THE PATIENT WAS PLACED ON BYPASS AND THE RUPTURED ANEURYSM WAS REPAIRED. ONCE THE REPAIR WAS COMPLETED, THE DS AND ESHEATH WERE REMOVED FROM THE FEMORAL ARTERY. FOLLOWING THE ESHEATH REMOVAL, AN INTIMAL TEAR IN THE ILIAC ARTERY WAS NOTED AND SURGICALLY REPAIRED. WHILE THE PATIENT WAS STILL ON BYPASS, THE TAVR PROCEDURE WAS CONVERTED TO THE TRANSAPICAL (TA) APPROACH. A 26MM SAPIEN XT VALVE WAS POSITIONED AND DEPLOYED WITHOUT ANY ISSUES AND THE PATIENT WAS PARTIALLY CLOSED. THE PATIENT WAS NOT ABLE TO COME OFF OF BYPASS AND EXPIRED DURING THE PROCEDURE. IT WAS REPORTED THAT THE SURGICAL TEAM WAS NOT AWARE OF THE THORACIC ANEURYSM OR THE EXTREME LEVEL OF AORTIC TORTUOSITY PRIOR TO THE TAVR PROCEDURE. THE PATIENT¿S NATIVE ANNULUS AREA MEASURED 509MM2 BY CT. SEVERE ANNULAR CALCIFICATION, SEVERE NATIVE VALVE LEAFLET CALCIFICATION AND SEVERE AORTIC ROOT CALCIFICATION WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716828 EDWARDS NOVAFLEX+ DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9355FS26 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death| R