BEUDAMED
    FDA Adverse Event Death Summary report: N

    ASCENDRA INTRODUCER SHEAT SET

    MDR report key: 3140447 · Received May 31, 2013

    Report

    Report Number
    2015691-2013-20221
    Event Type
    Death
    Date Received
    May 31, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 8, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 HAEMOSTATIC 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, PATIENT AND PROCEDURAL FACTORS APPEAR TO HAVE CAUSED AND/OR CONTRIBUTED TO THESE EVENTS. PER REPORT, THE EVENT WAS NOT RELATED TO DYSFUNCTION OF THE EDWARDS DEVICE. 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. 2015691-2013-20220.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS TERRITORY MANAGER, DURING A TRANSAPICAL TAVR PROCEDURE AFTER THE 23MM SAPIEN VALVE WAS DEPLOYED THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE. DURING THE FLUCTUATION OF PRESSURES THE PATIENT¿S VENTRICLE STARTED TO TEAR AT THE ACCESS SITE. THE PATIENT WAS MEDICALLY TREATED BY ANESTHESIA AND PLACED ON BYPASS, HOWEVER, THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS REPORTED AS HEMODYNAMIC INSTABILITY RELATED TO RAPID VENTRICULAR PACING. AN AUTOPSY WAS NOT PERFORMED. PER REPORT, THE SAPIEN VALVE WAS DEPLOYED WITHOUT INCIDENT. AN IMMEDIATE ECHO SHOWED A PERFECT RESULT BUT MINUTES LATER THE PATIENT¿S BLOOD PRESSURE DECREASED INTO THE 50SMMHG RANGE, WHICH PROMPTED TREATMENT BY THE ANESTHESIOLOGIST. WHEN THE DELIVERY SYSTEM AND THE SHEATH WERE REMOVED FROM THE PATIENT AND THE VENTRICLE WAS CLOSED THE PATIENT¿S BLOOD PRESSURE WAS THE 50-60'SMMHG RANGE; HOWEVER, IT INCREASED TO 230/50MMHG AND THE VENTRICLE STARTED TO TEAR AT THE ACCESS SITE. THE TEAM ATTEMPTED TO CONTROL THE BP WITH PACING SO THEY COULD REPAIR THE VENTRICLE BUT THEN THE SYSTOLIC PRESSURE DID NOT RECOVER AND REMAINED AROUND 45-50MMHG. AT THAT POINT, THE TEAM DECIDED TO PLACE THE PATIENT ON PERIPHERAL BYPASS BUT THE PATIENT EXPIRED BEFORE THIS COULD BE COMPLETED. THE TEAM FELT THAT THE PATIENT¿S VENTRICLE WAS UNABLE TO HANDLE MULTIPLE INCREASES AND DECREASES IN BLOOD PRESSURE AND PACING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242314 ASCENDRA INTRODUCER SHEAT SET AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9100IS 59401324

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Death| R