BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RETROFLEX 3 DILATOR KIT

    MDR report key: 3033987 · Received April 3, 2013

    Report

    Report Number
    2015691-2013-19730
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DRE
    PMA / PMN Number
    K093554
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), CARDIOVASCULAR COMPLICATIONS, INCLUDING PERFORATION OR DISSECTION OF VESSELS WHICH MAY REQUIRE INTERVENTION, ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE. THE EDWARDS SAPIEN/RF3 TRAINING MANUAL INSTRUCTS ON PROCEDURAL CONSIDERATIONS FOR DILATOR AND SHEATH INSERTION WITH REGARDS TO PROPER SCREENING CRITICAL TO REDUCING VASCULAR COMPLICATIONS. THE TRAINING MANUAL INSTRUCTS THE OPERATOR ON PROPER SHEATH INSERTION AND WITHDRAWAL TECHNIQUES, INCLUDING PRE-DILATING THE VESSEL WITH THE EDWARDS DILATORS. THE PHYSICIAN TRAINING MANUAL ALSO NOTES THAT CALCIFICATION MAY REDUCE LUMEN DIAMETER AND LIMIT OR PREVENT TRANSFEMORAL PASSAGE OF THE DEVICES. THE MINIMUM REQUIRED VESSEL DIAMETER FOR A 24 FR SHEATH IS 8MM. IN THIS CASE, THE ACCESS VESSEL'S MINIMUM LUMINAL DIAMETER WAS REPORTED AS 8MM, AND THE VESSELS WERE REPORTED AS MILDLY CALCIFIED AND MILDLY TORTUOUS. ADVANCEMENT OF THE LARGE BORE DILATOR (28FR) AGAINST RESISTANCE IN THE BORDERLINE DIAMETER VESSEL WITH MILD CALCIFICATION AND TORTUOSITY LIKELY CAUSED OR CONTRIBUTED TO THE VASCULAR COMPLICATION. 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 TERRITORY MANAGER, SERIAL DILATATION UP TO THE 28F DILATOR WAS SUCCESSFUL IN THE PATIENT'S LEFT SIDE ACCESS VESSEL. WHEN ADVANCING THE 24F INTRODUCER SHEATH SIGNIFICANT RESISTANCE WAS MET AND THE SHEATH COULD NOT BE FULLY ADVANCED. THE TAVR TEAM ELECTED TO SWITCH TO THE PATIENT'S RIGHT SIDE FOR ACCESS; HOWEVER THE 28F DILATOR COULD NOT BE ADVANCED. UPON REMOVAL OF THE DILATOR THE PATIENT'S BLOOD PRESSURE DROPPED. AN OCCLUSION BALLOON WAS QUICKLY PLACED IN THE AORTA VIA THE LEFT SIDE. CONTRAST INJECTION SHOWED A PERFORATED RIGHT EXTERNAL ILIAC. THREE COVERED STENT GRAFTS WERE PLACED TO COVER THE PERFORATION. IT WAS REPORTED THE PATIENT TOLERATED THE PROCEDURE WELL. ADDITIONAL INVESTIGATION REVEALED THE FOLLOWING: THE MINIMUM LUMINAL DIAMETER OF THE VESSEL AT THE ACCESS SITE WAS 8 MM. THE VESSELS WERE REPORTED TO BE MILDLY CALCIFIED AND MILDLY TORTUOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137238 RETROFLEX 3 DILATOR KIT DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE EDWARDS LIFESCIENCES 9100DKS7 59304395

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention