BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RETROFLEX 3 INTRODUCER SEATH SET

    MDR report key: 3102951 · Received May 9, 2013

    Report

    Report Number
    2015691-2013-20040
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYB
    PMA / PMN Number
    K093877
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT WAS DISCARDED. IN ADDITION, A DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT REQUIRED OR PERFORMED AS THERE WAS NO ALLEGATION OF PRODUCT MALFUNCTION. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), VASCULAR COMPLICATIONS ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE TAVR PROCEDURE. THE EDWARDS THV PATIENT SCREENING AND TRAINING MANUALS INSTRUCTS THE OPERATOR ON PROCEDURAL CONSIDERATIONS FOR SHEATH INSERTION WITH REGARDS TO PROPER SCREENING CRITICAL TO REDUCING VASCULAR COMPLICATIONS. THE TRAINING MANUALS INSTRUCT THE OPERATOR ON PROPER SHEATH INSERTION AND WITHDRAWAL TECHNIQUES, INCLUDING PRE-DILATING THE VESSEL WITH THE EDWARDS DILATORS. THE MANUALS ALSO NOTE THAT CALCIFICATION MAY REDUCE LUMEN DIAMETER AND LIMIT OR PREVENT TRANSFEMORAL PASSAGE OF THE DEVICES. THE INSTRUCTIONS FOR USE (IFU) CONTRAINDICATE THE USE OF THE DEVICE IN PATIENTS WITH ILIO-FEMORAL VESSEL CHARACTERISTICS THAT WOULD PRECLUDE SAFE PLACEMENT OF SHEATHS, SUCH AS SEVERE OBSTRUCTIVE CALCIFICATION OR SEVERE TORTUOSITY. PRE-PROCEDURE SCREENING AND ASSESSMENT OF THE FEMORAL AND ILIAC ARTERY INTERNAL DIAMETERS WILL ENABLE THE CLINICIAN TO DETERMINE IF THE THV VALVE CAN BE DELIVERED TRANSFEMORALLY. ASSESSMENT OF LOCATION AND AMOUNT OF CIRCUMFERENTIAL CALCIUM WILL AID IN DETERMINING AREAS OF REDUCED VESSEL DIAMETERS. THE OPERATORS ARE TRAINED TO MEASURE MINIMUM VESSEL DIAMETER TAKING CALCIUM INTO ACCOUNT. THE MINIMUM REQUIRED VESSEL DIAMETER FOR A 24F SHEATH IS 8.0MM. IN THIS CASE, THE ACCESS VESSEL WAS 8MM AND THE VESSELS WERE INDICATED TO BE MILDLY CALCIFIED AND MILDLY TORTUOUS. THE TRANSFEMORAL TAVR PROCEDURE REQUIRES THE INSERTION OF LARGE BORE DEVICES, AND THERE IS A RISK THAT PLACEMENT OF THE SHEATH AND/OR DILATORS MAY RESULT IN OR CONTRIBUTE TO VESSEL DAMAGE. IN THIS CASE, PER REPORT, THE PERCEIVED ROOT CAUSE FOR THE REPORTED INJURY IS DUE TO CALCIUM IN THE RIGHT COMMON ILIAC WHICH MAY NOT HAVE BEEN APPRECIABLE ON IMAGING. SINCE THERE IS NO ALLEGATION OF DEVICE MALFUNCTION, OR LABELING ISSUES, AND THE DEVICE WAS NOT RETURNED FOR PHYSICAL EVALUATION, NO FURTHER INVESTIGATIONAL ACTIVITIES WILL BE PERFORMED. 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 PREVENTIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS SALES REPRESENTATIVE, DURING THE TRANSFEMORAL TAVR PROCEDURE, THE PHYSICIAN REPORTED FEELING RESISTANCE WHEN ATTEMPTING TO REMOVE THE SHEATH. IN ORDER TO TROUBLESHOOT, A VASCULAR SURGEON WAS CALLED IN ORDER TO PERFORM A RETROPERITONEAL CUT-DOWN AND GAIN CONTROL OF THE RIGHT ILIAC SYSTEM. ONCE THE SHEATH WAS REMOVED IT WAS NOTED THAT A 10MM SECTION OF THE ILIAC ARTERY WAS ADHERED TO DEVICE. IN ORDER TO REPAIR THE ARTERY, AN 8 MM VASCULAR GRAFT WAS SUCCESSFULLY PLACED WITH MINIMAL BLOOD LOSS REPORTED. THE PATIENT WAS NOTED TO HAVE REMAINED IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203923 RETROFLEX 3 INTRODUCER SEATH SET INTRODUCER, CATHETER DYB EDWARDS LIFESCIENCES 9120S26 59264898

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention