BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RETROFLEX 3 INTRODUCER SHEATH SET

    MDR report key: 2940253 · Received February 2, 2013

    Report

    Report Number
    2015691-2013-19184
    Event Type
    Injury
    Date Received
    February 2, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 29, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYB
    PMA / PMN Number
    K093877
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 WERE NO EDWARDS REPRESENTATIVES PRESENT AT THE PROCEDURE; HOWEVER, 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. IN THIS CASE, PER REPORT, THE VASCULAR INJURY WAS RELATED TO A PREEXISTING PSEUDO ANEURYSM FROM A PREVIOUS HEART CATHETERIZATION. 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, FOLLOWING THE INABILITY TO ADVANCE THE 22FR EDWARDS SHEATH THE PATIENT DEVELOPED AN INJURY TO THE RIGHT FEMORAL ARTERY WHICH REQUIRED SURGICAL REPAIR. PER REPORT, THE INJURY WAS DUE TO A PSEUDO ANEURYSM IN THE RIGHT FEMORAL ARTERY FROM A PREVIOUS HEART CATHETERIZATION. THE PROCEDURE WAS CONVERTED TO AN OFF-LABEL TRANSVENOUS TRANS-SEPTAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. FOLLOWING THE REPAIR OF THE FEMORAL ARTERY, THE PATIENT WAS NOTED TO BE IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45442 RETROFLEX 3 INTRODUCER SHEATH SET INTRODUCER, CATHETER DYB EDWARDS LIFESCIENCES 9120S23

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention