BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS RETROFLEX 3 SHEATH

    MDR report key: 3031730 · Received April 2, 2013

    Report

    Report Number
    2015691-2013-19714
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYB
    PMA / PMN Number
    K093877
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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 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 24 FR SHEATH IS 8MM. IN THIS CASE, THE ACCESS VESSEL'S MINIMUM LUMINAL DIAMETER WAS 7.8MM, AND THE VESSELS WERE NOTED TO BE MILDLY CALCIFIED AND MILDLY TORTUOUS. ALTHOUGH IT CANNOT BE CONFIRMED, IT IS POSSIBLE THAT THE BORDERLINE SIZE OF THE VESSEL IN COMBINATION WITH CALCIFICATION AND/OR TORTUOSITY THAT WAS 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 TERRITORY MANAGER, UPON REMOVAL OF THE SHEATH THERE WAS A SMALL DISSECTION NOTED AT THE LEFT EXTERNAL ARTERY, WHICH REQUIRED THE PLACEMENT OF A STENT. PER REPORT, INITIALLY THE 24FR SHEATH WOULD NOT ADVANCE. THE PHYSICIAN THEN USED THE 22FR SHEATH, WHICH INSERTED WITHOUT DIFFICULTY. NO DIFFICULTIES WERE ENCOUNTERED WHEN DILATING THE VESSELS PRIOR TO SHEATH INSERTION. THE PATIENT WAS NOTED TO BE IN STABLE CONDITION POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135341 EDWARDS RETROFLEX 3 SHEATH INTRODUCER, CATHETER DYB EDWARDS LIFESCIENCES 9120S23

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention