BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENDRA+ INTRODUCER SHEATH

    MDR report key: 4241605 · Received November 10, 2014

    Report

    Report Number
    2015691-2014-02656
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 16, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED: THE OPERATOR NOTICED THE TEAR DURING REMOVAL OF THE SHEATH. IT IS NOT CLEAR IF THE TEAR OCCURRED DURING REMOVAL OR WHEN SUTURING THE SHEATH ON THE APEX. ACCORDING TO THE PHYSICIAN¿S COMMENT, THE LATER IS PROBABLE. THE SUTURE MIGHT HAVE BEEN PLACED TOO DEEP WHEN SECURING THE LEFT VENTRICLE APICAL ACCESS SITE, CAUSING THE TEAR OF THE APEX. THE PATIENT WAS ALREADY DISCHARGED IN A STABLE CONDITION. PER THE INSTRUCTIONS FOR USE (IFU), ACCESS SITE COMPLICATIONS/CARDIOVASCULAR INJURY, INCLUDING PERFORATION OF THE VENTRICLE OR MYOCARDIUM, BLEEDING, AND INJURY AT THE SITE OF VENTRICULAR ACCESS THAT MAY REQUIRE REPAIR ARE POTENTIAL COMPLICATIONS ASSOCIATED WITH THE TRANSAPICAL TAVR PROCEDURE. PER LITERATURE REVIEW, RISK FACTORS FOR APICAL LACERATION AND BLEEDING INCLUDE FRIABLE TISSUE, FATTY APEX, CHRONIC STEROID USE, DILATED LV WITH THINNED WALLS, AND HYPERTENSION DURING REMOVAL OF THE SHEATH. WHILE PATIENT CHARACTERISTICS ARE IMPORTANT, ACHIEVING GOOD HEMOSTATIC CONTROL OF THE LV APEX IS ONE OF THE MOST CRITICAL STEPS IN ENSURING THE SUCCESS OF THE TRANSAPICAL PROCEDURE, PARTICULARLY IN THE ELDERLY WITH FRIABLE TISSUE. ADDITIONAL LITERATURE REVIEW CONFIRMS THERE IS A HIGHER INCIDENCE OF APICAL BLEEDING IN FEMALE PATIENTS AND PATIENTS OVER 80 YEARS OLD. THIS INFORMATION CORRELATES WITH REVIEW OF COMPLAINT HISTORY, REVEALING THAT THE MAJORITY OF APICAL BLEEDING COMPLICATIONS APPEAR TO BE RELATED TO SURGICAL TECHNIQUE AND/OR DISEASED VENTRICLES DURING THE INSERTION OR REMOVAL OF THE SHEATH. THE THV TRAINING MANUALS NOTE THAT THAT REMOVAL OF THE SHEATH AND ATTEMPTED CLOSURE OF THE APICAL INCISION MAY BE ASSOCIATED WITH BLOOD LOSS. RAPID BURST PACING CAN BE USED TO LOWER THE SYSTEMIC BLOOD PRESSURE DURING SHEATH REMOVAL AND APICAL CLOSURE. THE THV TRAINING MANUALS ALSO RECOMMEND THE PHYSICIAN CONSIDER PERFORMING THE PROCEDURE UNDER FULL CPB SUPPORT FOR CERTAIN PATIENTS, INCLUDING THOSE WITH CARDIOGENIC SHOCK (CARDIAC INDEX < 2 L/MIN PER SQUARE METER) DESPITE VOLUME CHALLENGE AND INOTROPIC SUPPORT, PROFOUND LV, RV, OR BIVENTRICULAR DYSFUNCTION, AND NOTABLY FRIABLE APEX. IN THIS CASE, THE CAUSE OF THE APICAL TEAR AT THE SHEATH ACCESS SITE CANNOT BE CONFIRMED; HOWEVER, IT IS POSSIBLE THAT PROCEDURAL FACTORS (APEX SUTURING) AND PATIENT FACTORS (I.E. (B)(6) YEARS OLD FEMALE) MAY HAVE CONTRIBUTED TO THE EVENT. 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

    AS REPORTED BY OUR (B)(4) AFFILIATE, DURING A TRANSAPICAL TAVR PROCEDURE, THE PATIENT¿S BASELINE BLOOD PRESSURE OF 99/50MMHG DROPPED AND SHE WAS PLACED ON PERCUTANEOUS CARDIOPULMONARY SUPPORT (PCPS). DURING DEPLOYMENT OF THE SAPIEN XT, THE VALVE MOVED VENTRICULAR, AND THE DELIVERY SYSTEM AND VALVE WERE PUSHED AORTIC. THE VALVE LANDED 90:10 AORTIC/VENTRICULAR. WHILE WITHDRAWING THE SHEATH, THE LV APEX WAS FOUND TO BE TORN. TOTAL BLOOD VOLUME LOSS WAS 1200-1500ML. IV FLUID AND BLOOD TRANSFUSIONS WERE ADMINISTERED. THE TOTAL TRANSFUSION VOLUME WAS 3000ML. THE APEX WAS SUTURED, AND FIBRIN GLUE WAS APPLIED TO THE APEX. PROTAMINE WAS GIVEN TO REVERSE THE HEPARIN. A CHEST TUBE WAS PLACED AND THE APEX WAS CLOSED. THE PATIENT WAS TRANSFERRED TO THE ICU IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722650 ASCENDRA+ INTRODUCER SHEATH AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9350IS26J 59681097

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention