BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS ASCENDRA INTRODUCER SHEATH SET

    MDR report key: 3041381 · Received April 8, 2013

    Report

    Report Number
    2015691-2013-19768
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE, HYPOTENSION IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH STANDARD CARDIAC CATHETERIZATION, BALLOON VALVULOPLASTY (BAV), THE USE OF ANESTHESIA, AORTIC VALVE REPLACEMENT AND THE TAVR PROCEDURE. HYPOTENSION IS EXTREMELY COMMON DURING THE TRANSAORTIC VALVE IMPLANT PROCEDURE AND HAS MULTIPLE POTENTIAL ETIOLOGIES, INCLUDING THE EFFECTS OF ANESTHESIA AND RAPID VENTRICULAR PACING, AND IS REQUIRED DURING BAV AND SUBSEQUENT VALVE DEPLOYMENT. IN THIS CASE, THE ETIOLOGY OF THE HYPOTENSION CANNOT BE CONFIRMED. THE INTRAOPERATIVE HYPOTENSION OCCURRED AFTER INITIAL PLACEMENT OF THE SHEATH HOWEVER THERE WAS NO EVIDENCE OF AN ACCESS RELATED COMPLICATION. IT IS POSSIBLE THAT THE TAVR PROCEDURE INCLUDING ANESTHESIA, THE PATIENT'S UNDERLYING HEART DISEASE, AS WELL AS THE PVL POST VALVE DEPLOYMENT MAY HAVE CONTRIBUTED TO THE HYPOTENSION DURING THE PROCEDURE. 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 FIELD CLINICAL SPECIALIST, THAT DURING THE INSERTION OF THE ASCENDRA SHEATH THE PATIENT'S BLOOD PRESSURE DROPPED TO 80/40. THE ANESTHESIOLOGIST ADMINISTERED VASOPRESSORS AND BAV WAS PERFORMED UNDER RVP. THE PATIENT'S BLOOD PRESSURE REMAINED AT 60/30 AFTER COMPLETION OF BAV. THE PATIENT SOMEWHAT STABILIZED FOR A SHORT PERIOD OF TIME WITH MEDICATION TITRATION. A 23MM SAPIEN VALVE WAS IMPLANTED AND TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) SHOWED THE VALVE IN A 70:30 AORTIC POSITION WITH MODERATE PARAVALVULAR LEAK (PVL). POST DILATION OF THE VALVE, WITH THE ADDITION OF 1CC TO THE BALLOON, DID NOT PRODUCE A MARKED CHANGE IN THE PVL. THE PATIENT WAS UNSTABLE AGAIN REQUIRING PACING, CPR, AND BYPASS SUPPORT. THE TAVR TEAM ELECTED TO PLACE A SECOND VALVE 4MM VENTRICULAR TO THE FIRST TO CORRECT THE PVL. THERE WAS IMPROVED MODERATE PVL HOWEVER POST DILATION WAS PERFORMED AND THIS REDUCED THE PVL TO MILD. THE SURGICAL SITE WAS SUTURED AND CLOSED. THE PATIENT WAS REMOVED FROM CPB AND TRANSFERRED TO THE ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143152 EDWARDS ASCENDRA INTRODUCER SHEATH SET AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9100IS 59309546

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Required Intervention