BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RETROFLEX 3 INTRODUCER SHEATH SET

    MDR report key: 2832862 · Received November 14, 2012

    Report

    Report Number
    2015691-2012-18654
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 17, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYB
    PMA / PMN Number
    K093877
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), VASCULAR COMPLICATIONS ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE TAVR PROCEDURE. THE IFU CONTRAINDICATES PATIENTS WITH ILIO-FEMORAL VESSEL CHARACTERISTICS THAT WOULD PRECLUDE SAFE PLACEMENT OF SHEATHS AND DILATORS SUCH AS SEVERE OBSTRUCTIVE CALCIFICATION OR SEVERE TORTUOSITY. PER THE EDWARDS TRAINING MANUALS, PRE-PROCEDURE SCREENING AND ASSESSMENT OF THE FEMORAL AND ILIAC ARTERY INTERNAL DIAMETERS WILL ENABLE THE CLINICIAN TO DETERMINE IF THE SAPIEN 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 24FR SHEATH IS 8.0MM. IN THIS CASE, THE PATIENT'S MINIMUM LUMINAL DIAMETER WAS NOTED TO BE 8.6 MM, WITH MILD DEGREE OF TORTUOSITY AND CALCIFICATION. 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, THE EXACT CAUSE FOR THE REPORTED VASCULAR EVENT CANNOT BE CONFIRMED; HOWEVER, IT IS POSSIBLE THAT THE MILD CALCIFICATION AND/ OR TORTUOSITY WHICH MAY NOT BE VISIBLE IN THE IMAGING MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. SINCE THERE IS NO ALLEGATION OF DEVICE MALFUNCTION, OR LABELING ISSUES, NO FURTHER INVESTIGATIONAL ACTIVITIES WILL BE PERFORMED. THE IFUS 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 TERRITORY MANAGER, DURING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE, POST DEPLOYMENT OF THE EDWARDS SAPIEN VALVE, UPON REMOVAL OF THE RETROFLEX3 INTRODUCER SHEATH A DISSECTION OF THE LEFT COMMON DISTAL ILIAC WAS NOTICED. A 10MM COVERED STENT WAS PLACED TO REPAIR THE DISSECTION. NO FLOW LIMITING ISSUES WERE NOTED. THE PATIENT LEFT THE ROOM WITH OPEN ILIAC VESSELS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention