BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RETROFLEX 3 INTRODUCER SHEATH SET

    MDR report key: 2955907 · Received February 11, 2013

    Report

    Report Number
    2015691-2013-19251
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 15, 2013
    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 EDWARDS THV PATIENT SCREENING AND TRAINING MANUALS INSTRUCT THE OPERATOR ON PROCEDURAL CONSIDERATIONS FOR SHEATH INSERTION WITH REGARDS TO PROPER SCREENING CRITICAL TO REDUCING VASCULAR COMPLICATIONS. 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 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 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. THE MINIMUM REQUIRED VESSEL DIAMETER FOR A 24FR SHEATH IS 8 MM. PER THE REPORT THIS PATIENT'S ACCESS VESSEL HAD A BORDERLINE MLD FOR A 24FR SHEATH. IN THIS CASE, THE ROOT CAUSE FOR THE REPORTED VASCULAR INJURIES CANNOT BE CONFIRMED; HOWEVER, IT WAS REPORTED THAT THE PATIENT¿S ACCESS VESSEL TURNED OUT TO BE MORE TORTUOUS THAN WHAT THE SCREENING IMAGES HAD PREDICTED. IT IS POSSIBLE THAT THE PATIENT'S BORDERLINE VESSEL SIZE FOR A 24F SHEATH, IN COMBINATION WITH THE ACCESS VESSEL TORTUOSITY CAUSED OR CONTRIBUTED TO THE REPORTED 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 AT THIS TIME.

    Description of Event or Problem · 1

    PER REPORT, DIFFICULTY WAS ENCOUNTERED DURING INSERTION OF THE DELIVERY SYSTEM THROUGH THE RETROFLEX3 SHEATH. UPON REMOVAL OF THE SHEATH A DISSECTION WAS NOTED IN THE LEFT COMMON AND LEFT EXTERNAL ILIAC ARTERIES, AND THE LEFT FEMORAL ARTERY HAD RUPTURE. THESE VASCULAR INJURIES WERE RESOLVED WITH A COVERED STENT (ABBOTVASC ABSOLUTE STENT) 10X100MM. 3 UNITS OF BLOOD WERE GIVEN AND THE PATIENT LEFT THE CCL STILL INTUBATED. ADDITIONAL INFORMATION OBTAINED THROUGH INVESTIGATION: THE ACCESS VESSEL HAD A BORDERLINE MINIMUM LUMINAL DIAMETER (MLD) FOR A 24FR SHEATH; IN ADDITION, THE VESSEL TURNED OUT TO BE MORE TORTUOUS THAN WHAT THE SCREENING IMAGES PREDICTED. NOTHING UNUSUAL WAS NOTICED WHEN PREPPING THE SHEATH OR THE RF3 DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59467 RETROFLEX 3 INTRODUCER SHEATH SET INTRODUCER, CATHETER DYB EDWARDS LIFESCIENCES 9120S26 59320435

    Patients

    Seq Age Sex Outcome Treatment
    1 100 YR Required Intervention