BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENDRA INTRODUCER SHEAT SET

    MDR report key: 3120424 · Received May 20, 2013

    Report

    Report Number
    2015691-2013-20121
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EDWARDS WAS NOTIFIED THAT THE PATIENT EXPERIENCED NEUROLOGICAL SYMPTOMS 4-5 DAYS LATER AND SUBSEQUENTLY EXPIRED (MDR SUBMITTED FOR SAPIEN VALVE- STROKE). PER THE INSTRUCTIONS FOR USE (IFU), ACCESS SITE COMPLICATIONS/CARDIOVASCULAR INJURY, SUCH AS PERFORATION OR DAMAGE (DISSECTION) OF VESSELS, VENTRICLE, MYOCARDIUM OR VALVULAR STRUCTURES ARE KNOWN COMPLICATIONS ASSOCIATED WITH THE TRANSAPICAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. 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. THE LITERATURE ALSO REPORTS THAT FRIABLE TISSUE MAY PREDISPOSE THIS PATIENT POPULATION TO THE DEVELOPMENT OF APICAL ACCESS SITE COMPLICATIONS. IN THIS CASE, IT WAS REPORTED THAT THE APEX BLEEDING WAS A RESULT OF THE PATIENT¿S VERY FRIABLE TISSUE. 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; THEREFORE NO FURTHER ACTIONS ARE REQUIRED. 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.

    Description of Event or Problem · 1

    AS REPORTED PER THE EDWARDS FIELD CLINICAL SPECIALIST (FCS), UPON REMOVAL OF THE ASCENDRA SHEATH, MAJOR BLEEDING OCCURRED. THE PHYSICIAN MENTIONED THAT THE APEX OF THE HEART WAS VERY FRIABLE AND FATTY AND WITH EACH SUTURE BITE THEY COULD FEEL THE DELICACY OF THE HEART. THE ECHOCARDIOGRAPHER NOTICED A HOLE IN THE LEFT VENTRICLE AT THE VENTRICULOTOMY SITE SO IT WAS DECIDED TO GO ON BYPASS IN ORDER TO DECOMPRESS THE HEART AND FIX THE HOLE WITH FELT GRAFTS AND SUTURES. AFTER FIXING THE HOLE, THE PATIENT WAS TAKEN OFF OF PUMP AND THE APICAL EXPOSURE WAS THEN CLOSED. THE PATIENT REMAINED STABLE THROUGHOUT THE ENTIRE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222591 ASCENDRA INTRODUCER SHEAT SET AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9100IS 59343988

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Required Intervention