BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RETROFLEX 3 INTRODUCER SHEATH SET

    MDR report key: 3083662 · Received April 29, 2013

    Report

    Report Number
    2015691-2013-19940
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYB
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AS THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), CARDIOVASCULAR COMPLICATIONS WHICH MAY REQUIRE INTERVENTION ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). THE EDWARDS TRAINING MANUAL INSTRUCTS ON PROCEDURAL CONSIDERATIONS FOR 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 PREDILATING 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 9MM, AND THE VESSELS WERE NOTED TO BE MODERATELY CALCIFIED AND MILDLY TORTUOUS. THE CAUSE FOR THE DISSECTION CANNOT BE CONFIRMED. IT WAS REPORTED THAT IT MAY HAVE BEEN CAUSED DURING SHEATH INSERTION. THERE WAS NO REPORT OF DIFFICULTIES ENCOUNTERED DURING SHEATH INSERTION. THE MODERATE CALCIFICATION AND MILD TORTUOSITY OF THE PATIENT'S ACCESS VESSELS MAY HAVE 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; 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), POST DEPLOYMENT OF THE SAPIEN VALVE, THE 24F SHEATH WAS REMOVED FROM THE RIGHT SIDE WITHOUT ISSUE AND SITE CLOSED WITH PERCLOSE DEVICE. THE POST ANGIOGRAM OF THE RIGHT COMMON ILIAC SHOWED A NARROWING IN THE VESSEL AT THE PERCLOSE SITE AND A DISSECTION. A CUT DOWN OF THE SITE WAS PERFORMED AND SURGICAL REPAIR WAS DONE ON THE RIGHT COMMON ILIAC ARTERY (NO STENT OR PATCH). THE PATIENT WAS STABLE AND WAS SENT TO THE CTICU. THE MINIMUM LUMINAL DIAMETER WAS 9MM, WITH MODERATE DEGREE OF CALCIFICATION AND MILD TORTUOSITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185315 RETROFLEX 3 INTRODUCER SHEATH SET INTRODUCER, CATHETER DYB EDWARDS LIFESCIENCES 9120S26 59315635

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention