BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RETROFLEX 3 INTRODUCER SHEATH SET

    MDR report key: 2802311 · Received October 24, 2012

    Report

    Report Number
    2015691-2012-18531
    Event Type
    Injury
    Date Received
    October 24, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 1, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYB
    PMA / PMN Number
    K093877
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT WAS DISCARDED BY THE SITE; HOWEVER, THERE WAS NO ALLEGATION OF DEVICE DYSFUNCTION. 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 8MM. IN THIS CASE, THE ACCESS VESSEL'S MINIMUM LUMINAL DIAMETER WAS 8.0MM, AND THE VESSELS WERE NOTED TO BE MODERATELY CALCIFIED AND MILDLY TORTUOUS. THE ROOT CAUSE FOR THE REPORTED DISSECTION CANNOT BE CONFIRMED. HOWEVER, IT IS POSSIBLE THAT THE BORDERLINE SIZE OF THE VESSEL IN COMBINATION WITH MODERATE CALCIFICATION AND MILD TORTUOSITY 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. A COMPLAINT HISTORY FOR THIS TYPE OF EVENT IS 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, A VASCULAR INJURY WAS NOTED WHEN ATTEMPTING TO REMOVE THE EDWARDS SHEATH. PER REPORT, THE SHEATH WAS INSERTED WITHOUT DIFFICULTY OR SIGNIFICANT RESISTANCE. PRECLOSE WAS PERFORMED USING THREE PERCLOSE PROGLIDE; HOWEVER, ONE OF THE PERCLOSE DEVICES FAILED. THE SAPIEN VALVE WAS DEPLOYED WITHOUT INCIDENT. DURING THE INITIAL ATTEMPT TO REMOVE THE SHEATH, THE PHYSICIAN NOTED THAT THE SHEATH SEEMED TO BE FIRMLY "STUCK". THE SHEATH WAS PULLED BACK SO THAT THE TIP WAS APPROXIMATELY 4-5MM DISTAL TO THE AORTO-ILIAC BIFURCATION. AT THIS POINT, AN ANGIOGRAM WAS PERFORMED AND THE ARTERY APPEARED TO BE INTACT. THE SHEATH WAS WITHDRAWN ANOTHER FEW MILLIMETERS AND AN ANGIOGRAM REVEALED A LARGE AREA OF EXTRALUMINAL CONTRAST FLOW. THE PATIENT'S BLOOD PRESSURE IMMEDIATELY DROPPED FROM 120 TO 80 SYSTOLIC. THE DILATOR WAS REINSERTED AND THE SHEATH WAS PUSHED IN FAR ENOUGH TO CREATE A TAMPONADE EFFECT. A BLOOD TRANSFUSION WAS INITIATED AND AN OCCLUSION BALLOON WAS INSERTED THROUGH THE CONTRALATERAL SIDE. MULTIPLE STENTS WERE DEPLOYED FROM THE AORTO-ILIAC BIFURCATION TO JUST ABOVE THE SHEATH INSERTION SITE. A VASCULAR SURGEON THEN PERFORMED A CUTDOWN TO THE SHEATH INSERTION SITE AND GRAFTED ONTO ONE OF THE STENTS TO BYPASS THE REMAINING DAMAGED ARTERY AT THE SHEATH INSERTION SITE. THE PATIENT WAS STABLE THROUGHOUT THE ENTIRE PROCEDURE REQUIRING NO PRESSORS. THE PATIENT RECEIVED AT LEAST SEVEN UNITS OF PACKED RED BLOOD CELLS (PRBC) AND WAS TRANSPORTED TO THE INTENSIVE CARE UNIT IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RETROFLEX 3 INTRODUCER SHEATH SET INTRODUCER, CATHETER DYB EDWARDS LIFESCIENCES 9120S26 59264898

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention