BEUDAMED
    FDA Adverse Event Death Summary report: N

    ASCENDRA INTRODUCER SHEATH SET

    MDR report key: 3171162 · Received June 14, 2013

    Report

    Report Number
    2015691-2013-20357
    Event Type
    Death
    Date Received
    June 14, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 22, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 INCLUDING ADDITIONAL HEPARIN ADMINISTRATION, 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 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

    IT WAS REPORTED BY THE EDWARDS TERRITORY MANAGER THAT AFTER SUCCESSFUL TRANSAPICAL DEPLOYMENT OF A 26MM SAPIEN VALVE THE SURGICAL TEAM BEGAN PACING FOR SHEATH WITHDRAWAL. THE SHEATH WAS WITHDRAWN AND THE PURSESTRING SUTURES WERE TIGHTENED AND BLEEDING WAS SEEN AROUND PURSESTRING SUTURES ON THE POSTERIOR LV. THE PATIENT WAS PUT ON CVB AND THE SURGEONS ATTEMPTED TO SUTURE AROUND PURSESTRING SUTURES BUT THE BLEEDING WOULD NOT STOP. THE SURGEONS WENT ON AND OFF PUMP SEVERAL TIMES IN AN EFFORT TO REDUCE PRESSURE AND PATCH THE LV. THE SURGEONS THEN PLACED A PATCH WITHIN THE LV AND OUTSIDE TO LV BUT THE BLEEDING CONTINUED. A TOTAL OF 5L OF BLOOD WERE GIVEN BACK TO THE PATIENT VIA CELL SAVER. THE SURGEONS CONTINUED FOR 2 PLUS HOURS POST THE EDWARDS TERRITORY MANAGER¿S DEPARTURE TO STOP BLEEDING IN THE LV BUT TO NO AVAIL. IT WAS REPORTED TO THE EDWARDS TERRITORY MANAGER, ON (B)(6) 2013, THAT THE PATIENT EXPIRED IN THE ROOM. REPORTEDLY THERE WERE NO REPORTED ISSUES DURING THE INITIAL ACCESS OF THE APEX AND INSERTION OF THE SHEATH. ADDITIONALLY THE PATIENT¿S APEX TISSUE WAS FRIABLE AND THE PHYSICIAN DESCRIBED IT AS ¿TISSUE PAPER¿. THE PATIENT ALSO RECEIVED AN ADDITIONAL DOSE (10,000 UNITS) OF HEPARIN DURING THE PROCEDURE AS THE ACT WAS 243.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271080 ASCENDRA INTRODUCER SHEATH SET AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES ASCENDRA SHEATH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Death