BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS ASCENDRA+ INTRODUCER SHEATH

    MDR report key: 4216815 · Received October 31, 2014

    Report

    Report Number
    2015691-2014-02575
    Event Type
    Injury
    Date Received
    October 31, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 8, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. ACCESS SITE INJURIES, INCLUDING DISSECTION OF THE AORTIC WALL DURING THE TRANSAORTIC APPROACH, ARE A WELL RECOGNIZED COMPLICATION OF THE TAVR PROCEDURE IN THIS ELDERLY POPULATION WITH MULTIPLE CO-MORBIDITIES. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE TRANSCATHETER HEART VALVE (THV). TRAINING INCLUDES PATIENT SCREENING, DEVICE PREPARATION, APPROACH, DEPLOYMENT, IMAGING, PROCEDURE-SPECIFIC TRAINING MANUALS AND PROCTORED PROCEDURES. THE THV TRAINING MANUALS INSTRUCT THE USER TO DETERMINE WITH CT IF THE PLANNED AORTIC ACCESS SITE IS FREE OF CALCIFICATION, ALLOWS THE SHEATH TO BE PLACED IN A STRAIGHT LINE, AND LEAVES ADEQUATE ROOM BETWEEN THE TIP OF THE SHEATH AND NATIVE AORTIC VALVE ANNULUS TO ALLOW FULL BALLOON EXPANSION. CONSIDERATIONS FOR APPROACH (PARTIAL J-STERNOTOMY OR RIGHT MINI-THORACOTOMY), ACCESS AND STABILIZATION OF THE SITE ARE ALSO PROVIDED IN THE TRAINING. IN THIS CASE, THERE WAS MILD LEAKING AROUND THE SHEATH AND A FAIR AMOUNT OF BLOOD BEING SUCTIONED FROM THE HUB OF THE SHEATH. IT IS POSSIBLE THAT THE PROCEDURE ITSELF, IN ADDITION TO THE PATIENT¿S ADVANCED AGE CONTRIBUTED TO THE BLEEDING. THE USE OF A CELL SAVER AND ADMINISTRATION OF BLOOD PRODUCTS CORRECTED THE 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.

    Description of Event or Problem · 1

    DURING THE TRANSAORTIC TAVR PROCEDURE, SEVERAL MINUTES AFTER THE INSERTION OF THE ASCENDRA+ INTRODUCER SHEATH, THE PATIENT¿S INVASIVE SYSTOLIC BLOOD PRESSURE (SBP) WAS READING 50-60MMHG. VASOPRESSORS WERE ADMINISTERED BEFORE PROCEEDING WITH THE BALLOON AORTIC VALVULOPLASTY (BAV). AT THIS TIME THE HEMOGLOBIN WAS 7.8MG/DL; DECREASED FROM THE BASELINE HEMOGLOBIN OF 9MG/DL. ANGIOGRAPHY WAS PERFORMED TO ASSESS PERCUTANEOUS SHEATH ACCESS, WHICH LOOKED FINE. IT WAS DETERMINED AT THIS TIME THAT THE CELL SAVER WAS NOT IN USE. THE AORTA AROUND THE SHEATH WAS LEAKING MILDLY AND THE SURGEON WAS SUCTIONING A FAIR AMOUNT OF BLOOD FROM THE HUB OF THE SHEATH WITH THE WIRE IN PLACE. THE SUCTION CANISTER CONTAINED 1 LITER OF BLOOD, IN ADDITION TO 4 SOAKED LAP SPONGES. BLOOD PRODUCTS WERE INFUSED, AND FLUIDS AND VASOPRESSORS WERE ADMINISTERED. THE CELL SAVER WAS STARTED AND THE SUCTION WAS REMOVED FROM THE HUB OF THE SHEATH. THE PATIENT¿S SBP RECOVERED TO 110MMHG AND THE CASE PROCEEDED. A 29MM SAPIEN XT VALVE WAS DEPLOYED WITH A FINAL 60:40 AORTIC/VENTRICULAR (A/V) POSITION, RESULTING IN MILD PARAVALVULAR LEAK (PVL). THE PATIENT REMAINED HEMODYNAMICALLY UNSTABLE. VASOPRESSORS WERE ADMINISTERED BY IV PUMP. THREE (3) LITERS OF BLOOD WAS TRANSFUSED. THE INCISIONS WERE CLOSED IN NORMAL FASHION AND THE PROCEDURE WAS COMPLETED. THE PATIENT WAS TRANSFERRED TO THE ICU. POSTOPERATIVE DAY (POD) 1, THE PATIENT WAS REPORTED TO BE STABLE AND DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699884 EDWARDS ASCENDRA+ INTRODUCER SHEATH AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9350IS29 59795607

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention