BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENDRA INTRODUCER SHEATH SET

    MDR report key: 3170034 · Received June 14, 2013

    Report

    Report Number
    2015691-2013-20346
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    April 17, 2013
    Report Date
    May 23, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SHEATH WAS NOT RETURNED TO EDWARDS FOR EVALUATION AS IT WAS DISCARDED. IN ADDITION, A DESIGN HISTORY RECORD (DHR) REVIEW WAS NOT PERFORMED AS THERE WAS NO ALLEGATION OF A DEVICE MALFUNCTION. 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. IN THIS CASE, THE EXACT CAUSE OF THE REPORTED EVENT IS UNKNOWN; HOWEVER, IT IS POSSIBLE THAT THE PATIENT¿S UNDERLYING CO-MORBIDITIES, ADVANCED AGE ((B)(6)) AND FEMALE GENDER MAY HAVE ALSO INCREASED THE RISK FOR APICAL ACCESS BLEEDING. THERE WAS NO REPORT OF DIFFICULTY ADVANCING OR WITHDRAWING THE ASCENDRA SHEATH. 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

    AS REPORTED BY THE EDWARDS SALES REPRESENTATIVE, DURING THE TRANSAPICAL TAVR PROCEDURE, THE PATIENT WAS TRANSFUSED WITH BLOOD WHEN THERE WAS BLEEDING AT THE TIME OF THE APICAL INCISION AND INSERTION OF THE DELIVERY CATHETER. CASE SUMMARY: AT THE BEGINNING OF THE PROCEDURE AND PRIOR TO THE INSERTION OF THE SHEATH, THE PATIENT'S PRESSURE WAS NOTED TO HAVE STARTED TO DROP TO ABOUT 75 MMHG. AFTER THE 26F ASCENDRA SHEATH WAS PLACED, THE PRESSURE CONTINUED TO DROP TO 40 MMHG. THE TEAM THEN DECIDED TO PUT THE PATIENT ON CARDIOPULMONARY SUPPORT (CPS) AND THE PRESSURE WAS RESTORED. PER REPORT, 2 UNITS OF BLOOD HAD BEEN TRANSFUSED PRIOR TO THE PLACEMENT OF THE SHEATH. THE 23 MM SAPIEN VALVE WAS THEN PREPPED AND DEPLOYED IN PROPER POSITION. HOWEVER, POST DEPLOYMENT THE PATIENT DEVELOPED COMPLETE HEART BLOCK AND A TEMPORARY PACEMAKER HAD TO BE PLACED. THE PATIENT WAS EXTUBATED AND TRANSFERRED TO THE CRITICAL CARE UNIT WITH EPICARDIAL PACING LEADS IN PLACE. THE PATIENT WAS NOTED TO HAVE LEFT THE OPERATING ROOM IN STABLE CONDITION. ADDITIONAL INFORMATION PROVIDED BY THE EDWARDS SALES REPRESENTATIVE, INDICATED THE PATIENT HAD NOT BEEN TRANSFUSED WITH BLOOD PROPHYLACTICALLY BUT ONLY WHEN THERE WAS BLEEDING AT THE TIME OF THE APICAL INCISION AND INSERTION OF THE DELIVERY CATHETER. IN ADDITION, THE PATIENT WAS IMPLANTED WITH A PERMANENT PACEMAKER (PPM) WITHIN 30 DAYS FROM THE TAVR PROCEDURE FOR THE CHB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272072 ASCENDRA INTRODUCER SHEATH SET AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9100IS

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Required Intervention