BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS RETROFLEX 3 SHEATH

    MDR report key: 2992907 · Received March 7, 2013

    Report

    Report Number
    2015691-2013-19478
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 12, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYB
    PMA / PMN Number
    P100041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 NOVAFLEX 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 VESSEL DIAMETER FOR A 22FR SHEATH IS 7 MM. IN THIS CASE, THE ACCESS VESSEL'S MINIMUM LUMINAL DIAMETER WAS 7MM AT THE LOCATION OF THE DIFFICULTY, AND THE VESSELS WERE NOTED TO BE MODERATELY CALCIFIED AND MILDLY TORTUOUS. ALTHOUGH IT CANNOT BE CONFIRMED, IT IS LIKELY THAT THE BORDERLINE SIZE OF THE VESSEL IN COMBINATION WITH CALCIFICATION NOT APPRECIABLE ON IMAGING 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 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.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS SALES REPRESENTATIVE, UPON THE REMOVAL OF THE SHEATH A DISSECTION OF THE LEFT ILIAC ARTERY WAS NOTED. THE PHYSICIAN SUCCESSFULLY REPAIRED THE ARTERY USING A PATCH. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE, WAS EXTUBATED IN THE LAB AND RETURNED TO THE RECOVERY ROOM IN STABLE CONDITION. PER REPORT, THERE WAS SOME RESISTANCE WHEN ADVANCING THE 25FR DILATOR, BUT IT WAS SUCCESSFULLY ADVANCED AND REMOVED AND THE 22FR SHEATH WAS ADVANCED. PER THE DISCUSSION WITH THE OPERATORS, THE PERCEIVED CAUSE OF THE EVENT WAS THE BORDERLINE VESSEL SIZE IN COMBINATION WITH ILIOFEMORAL ARTERIES THAT HAD MORE CALCIUM THAN WAS APPRECIATED ON IMAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97082 EDWARDS RETROFLEX 3 SHEATH INTRODUCER, CATHETER DYB EDWARDS LIFESCIENCES 9120S23 59262570

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention