BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RETROFLEX 3 INTRODUCER SHEATH SET

    MDR report key: 3073576 · Received April 23, 2013

    Report

    Report Number
    2015691-2013-19891
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 2, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYB
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 THV 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. AS INDICATED IN THE DEVICE LABELING AND THV TRAINING MANUALS, THE MINIMUM REQUIRED VESSEL DIAMETER FOR A 22 FR RF3 SHEATH IS 7MM. IN THIS CASE, THE ACCESS VESSEL'S MINIMUM LUMINAL DIAMETER WAS 6.8MM, AND THE VESSELS WERE NOTED TO BE MODERATELY CALCIFIED. THE LESS THAN ADEQUATE MLD OF THE ACCESS VESSEL IN COMBINATION WITH MODERATE CALCIFICATION 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. IN ADDITION, THERE IS NO ALLEGATION OF DEVICE MALFUNCTION; 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), IN CLOSING THE PRIMARY ACCESS SIDE DURING A TRANSFEMORAL TAVR PROCEDURE, A DISSECTION WAS NOTICED IN THE LEFT COMMON FEMORAL ARTERY. THE DECISION WAS MADE TO IMPLANT A 9 X 4 VIABAHN STENT ALONG WITH A 10 X 5 SMART STENT IN THE USUAL FASHION TO REPAIR THE DISSECTION. THE FINAL RESULT WAS GOOD AND THE CASE FINISHED. PATIENT IS DOING FINE. PER REPORT, THE PATIENT'S MINIMUM LUMINAL DIAMETER WAS 6.8MM, AND THE PATIENT HAD MODERATE ACCESS VESSEL CALCIFICATION, AND NOT TORTUOSITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175347 RETROFLEX 3 INTRODUCER SHEATH SET INTRODUCER, CATHETER DYB EDWARDS LIFESCIENCES 9120S23

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention