BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENDRA INTRODUCER SHEATH SET

    MDR report key: 3092044 · Received May 3, 2013

    Report

    Report Number
    2015691-2013-19985
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. A DESIGN HISTORY RECORD (DHR) REVIEW WAS NOT PERFORMED AS THERE WAS NO ALLEGATION OF A DEVICE MALFUNCTION. PER THE INSTRUCTIONS FOR USE (IFU), COMPLICATIONS ASSOCIATED WITH THE TRANSAPICAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE INCLUDE CATHETER SITE BLEEDING WHICH MAY REQUIRE INTERVENTION AND CARDIOVASCULAR INJURY, SUCH AS PERFORATION OR DAMAGE (DISSECTION) OF VESSELS, VENTRICLE, MYOCARDIUM OR VALVULAR STRUCTURES. UPON REVIEW OF PRIOR EVENTS, THE MAJORITY OF APICAL BLEEDING COMPLICATIONS/VENTRICLE RUPTURES APPEAR TO BE RELATED TO SURGICAL TECHNIQUE AND/OR DISEASED VENTRICLES DURING THE INSERTION OR REMOVAL OF THE SHEATH. ADDITIONALLY, ACCORDING TO LITERATURE REVIEW, THERE IS A HIGHER INCIDENCE OF APICAL BLEEDING IN FEMALE PATIENTS AND PATIENTS OVER 80 YEARS OLD. FURTHERMORE, THE LITERATURE ALSO REPORTS THAT FRIABLE TISSUE MAY PREDISPOSE THIS PATIENT POPULATION TO THE DEVELOPMENT OF APICAL ACCESS SITE COMPLICATIONS. IN THIS CASE, THE EXACT CAUSE OF THE REPORTED EVENT IS UNKNOWN; HOWEVER, IT IS POSSIBLE THAT 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 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 AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, AFTER SUCCESSFUL PLACEMENT OF A 26MM SAPIEN VALVE VIA THE TRANSAPICAL APPROACH, ON CLOSURE OF THE APICAL ACCESS SITE THE PATIENT'S VENTRICULAR TISSUE TORE DURING SUTURING. DESPITE MULTIPLE SURGICAL ATTEMPTS, THE BLEEDING FROM THE APEX WAS DIFFICULT TO CONTROL. PER REPORT, RVP WAS USED TO REMOVE THE SHEATH. THE PATIENT WAS PLACED ON CARDIOPULMONARY BYPASS AND WAS CONVERTED TO STERNOTOMY. THE PATIENT WAS NOTED TO BE HEMODYNAMICALLY UNSTABLE AT THE END OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194208 ASCENDRA INTRODUCER SHEATH SET AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9100IS 59402275

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention