BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENDRA INTRODUCER SHEATH SET

    MDR report key: 3182111 · Received June 21, 2013

    Report

    Report Number
    2015691-2013-20399
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 30, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 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. THE EXACT CAUSE OF THE REPORTED APICAL BLEED IS NOT AVAILABLE; HOWEVER IT APPEARS THAT IN ADDITION TO PROCEDURAL FACTORS, PATIENT FACTORS (FRIABLE TISSUE, FEMALE GENDER, AND ADVANCED AGE) COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED 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 (B)(4) BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS (B)(4) REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST THAT AFTER SUCCESSFUL TRANSAPICAL DEPLOYMENT OF A 23 MM SAPIEN VALVE THE SURGICAL TEAM BEGAN PACING FOR SHEATH WITHDRAWAL. AFTER THE SHEATH WAS WITHDRAWN, THERE WAS SIGNIFICANT BLEEDING AROUND THE ACCESS SITE. MULTIPLE PLEDGETED SUTURES WERE REQUIRED TO ACHIEVE ADEQUATE HEMOSTASIS. THERE WAS 1600 ML OF BLOOD IN THE SUCTION CANISTER BY THE TIME CLOSURE WAS COMPLETED. MULTIPLE UNITS OF BLOOD WERE TRANSFUSED AND THE PATIENT WAS TRANSFERRED TO THE ICU IN A STABLE CONDITION. REPORTEDLY THERE WAS NO UNDUE TORQUE OR MOVEMENT OF THE SHEATH DURING THE PROCEDURE. ADDITIONALLY THE PATIENT¿S APEX TISSUE NOTED TO BE FRIABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281874 ASCENDRA INTRODUCER SHEATH SET AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9100IS 59310155

    Patients

    Seq Age Sex Outcome Treatment
    1 93 Required Intervention