BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RETROFLEX 3 INTRODUCER SHEATH SET

    MDR report key: 2963626 · Received February 15, 2013

    Report

    Report Number
    2015691-2013-19291
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 11, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYB
    PMA / PMN Number
    K093877
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT WAS DISCARDED BY THE SITE AND 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 SAPIEN/RF3 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 22 FR SHEATH IS 7MM. IN THIS CASE, THE ACCESS VESSEL'S MINIMUM LUMINAL DIAMETER WAS 5.9MM. ALTHOUGH IT CANNOT BE CONFIRMED, THE REPORTED VASCULAR COMPLICATION IS LIKELY DUE TO ADVANCEMENT OF A LARGE BORE SHEATH IN A LESS THAN ADEQUATELY SIZED VESSEL. 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, DURING THE TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) THE PATIENT DEVELOPED A DISSECTION OF THE RIGHT EXTERNAL ILIAC ARTERY (REIA). CASE SUMMARY: SERIAL DILATION WAS PERFORMED USING THE 18FR, 20FR, 22FR, 23FR AND 25FR DILATORS. THERE WAS RESISTANCE WITH THE 23FR AND 25FR DILATORS AT THE AORTOILIAC BIFURCATION. A PERIPHERAL BALLOON (8.0MM X 20CM) WAS USED AT THE RIGHT AORTOILIAC BIFURCATION TO HELP ADVANCE THE 23FR AND 25FR DILATORS. THE 22FR SHEATH WAS THEN INTRODUCED WITH MODERATE DIFFICULTY JUST BEYOND THE AORTOILIAC BIFURCATION. THE 23MM SAPIEN VALVE WAS THEN SUCCESSFULLY DEPLOYED. BEFORE THE SHEATH WAS REMOVED, THE MEDICAL TEAM THOUGHT THERE MIGHT HAVE BEEN A DISSECTION OF THE REIA. THE VASCULAR SURGEON INCREASED THE SURGICAL CUT DOWN INCISION AND DETERMINED THAT THERE WAS A DISSECTION OF THE REIA. THE VASCULAR SURGEON THEN PLACED A COVERED GRAFT BETWEEN THE RIGHT COMMON ILIAC ARTERY AND THE SUPERFICIAL FEMORAL ARTERY. AS A RESULT, NORMAL BLOOD FLOW WAS SUCCESSFULLY ACHIEVED. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE. THE PATIENT WAS THEN TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) FOR POST OPERATIVE MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68319 RETROFLEX 3 INTRODUCER SHEATH SET INTRODUCER, CATHETER DYB EDWARDS LIFESCIENCES 9120S23 59352996

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention