BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RETROFLEX 3/ SAPIEN INTRODUCER SHEATH SET

    MDR report key: 2873154 · Received December 13, 2012

    Report

    Report Number
    2015691-2012-18855
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 27, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYB
    PMA / PMN Number
    K093877
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SHEATH WAS NOT RETURNED FOR EVALUATION AS IT WAS REPORTED THAT THERE WERE NO ISSUES WITH THE DEVICE. 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 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 8 MM. IN THIS CASE, THE ACCESS VESSEL'S MINIMUM LUMINAL DIAMETER WAS 9.0 MM, AND THE VESSELS WERE NOTED TO BE MODERATELY TORTUOUS AND MODERATELY CALCIFIED. AS REPORTED, THE ROOT CAUSE OF THE DISSECTION WAS PERCEIVED AS DUE TO BORDERLINE ACCESS. IT IS ALSO POSSIBLE THAT THE MODERATE TORTUOUSITY AND MODERATE CALCIFICATION CONTRIBUTED TO THE EVENT. 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 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 PER THE EDWARDS CLINICAL SPECIALIST, DURING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE, AFTER THE SAPIEN VALVE WAS IMPLANTED SUCCESSFULLY, UPON SHEATH REMOVAL A SMALL DISSECTION WAS NOTED IN THE LEFT COMMON ILIAC ARTERY (LCIA). A 10 MM VIABAHN STENT WAS USED TO TREAT THE DISSECTION. POST PROCEDURE THE PATIENT WAS TRANSFERRED IN STABLE CONDITION. ADDITIONAL INVESTIGATION REVEALED THE FOLLOWING: THE MINIMUM LUMINAL DIAMETER OF THE ACCESS VESSEL WAS 9.0 MM, BUT THE MINIMUM LUMINAL DIAMETER OF THE VESSEL AT THE LOCATION OF THE DISSECTION IS UNKNOWN. THE VESSEL WAS DESCRIBED AS MODERATELY TORTUOUS AND MODERATELY CALCIFIED. PER REPORT, THE EVENT WAS NOT CAUSED BY A DEVICE MALFUNCTION. ALSO, NO DIFFICULTY WAS NOTED WHEN INSERTING THE SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RETROFLEX 3/ SAPIEN INTRODUCER SHEATH SET INTRODUCER, CATHETER DYB EDWARDS LIFESCIENCES 9120S26 59255097

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention