BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RETROFLEX 3 INTRODUCER SHEATH SET

    MDR report key: 3802248 · Received May 9, 2014

    Report

    Report Number
    2015691-2014-01087
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    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), CARDIOVASCULAR COMPLICATIONS, INCLUDING PERFORATION OR DISSECTION OF VESSELS WHICH MAY REQUIRE INTERVENTION, ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE TAVR PROCEDURE. ACCORDING TO LITERATURE REVIEW, AND AS DOCUMENTED IN A TECHNICAL SUMMARY WRITTEN BY EDWARDS LIFESCIENCES, VASCULAR COMPLICATIONS ARE A WELL RECOGNIZED COMPLICATION OF THE TRANSFEMORAL TAVR PROCEDURE IN THIS ELDERLY POPULATION WITH MULTIPLE CO-MORBIDITIES. EDWARDS HAS REVIEWED MANY REPORTS, INCLUDING SCREENING DATA RECORDS AND SOURCE DOCUMENTATION OF VASCULAR COMPLICATIONS AND HAS FOUND THAT THE ROOT CAUSE IS TYPICALLY RELATED TO A COMBINATION OF VESSEL SIZE, TORTUOSITY AND CALCIFICATIONS. ALTHOUGH THE INCIDENCE IS DECREASING WITH SMALLER SHEATH/DELIVERY SYSTEM SIZES AND PHYSICIAN EXPERIENCE, THERE WILL CONTINUE TO BE CASES IN WHICH VASCULAR COMPLICATIONS WILL OCCUR. THE THV PHYSICIAN TRAINING MANUALS INSTRUCT 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. IT ALSO NOTES THAT CALCIFICATION MAY REDUCE LUMEN DIAMETER AND LIMIT OR PREVENT TRANSFEMORAL PASSAGE OF THE DEVICES. THE IFU CONTRAINDICATES 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/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 PHYSICIAN TRAINING MANUAL ALSO LISTS THE MINIMUM RECOMMENDED VESSEL SIZE FOR EACH SIZE DEVICE. DESPITE THE BEST SCREENING TOOLS, A SMALL PERCENTAGE OF PATIENTS WILL HAVE FEMORAL/ILIAC VESSELS THAT ARE NOT AMENABLE TO THE TRANS-FEMORAL APPROACH OR WHERE INCREASED RESISTANCE IS ENCOUNTERED DURING INSERTION OF DEVICES. IN MANY CASES, THE VESSEL MINIMUM LUMINAL DIAMETER (MLD) MAY BE BORDERLINE OR BELOW THE INDICATED SIZE. IN ADDITION, SIGNIFICANT CALCIFICATION AND/OR TORTUOSITY, NOT ALWAYS APPRECIABLE ON IMAGING, COULD BE CONTRIBUTING FACTORS TO THE EVENT. THE MINIMUM REQUIRED VESSEL DIAMETER FOR A 24 FR SHEATH IS 8 MM. IN THIS CASE, THE MLD OF THE ACCESS VESSEL WAS 7.8 MM WITH MILD CALCIFICATION AND MILD TORTUOSITY. PER REPORT, THE PATIENT¿S LESS THAN ADEQUATE VESSEL SIZE AND MODERATELY CALCIFIED PORTION OF THE COMMON EXTERNAL ILIAC WERE BELIEVED TO HAVE CONTRIBUTED TO THE INSERTION DIFFICULTY OF THE SHEATH WHICH SUBSEQUENTLY RESULTED IN THE DISSECTION OF THE COMMON EXTERNAL ILIAC. 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 (B)(4) BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS (B)(4) REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    AFTER REMOVAL OF THE FEMORAL SHEATH, A DISSECTION WAS NOTED IN THE AREA OF THE COMMON EXTERNAL ILIAC. PER REPORT, THE SHEATH HAD BEEN DIFFICULT TO ADVANCE DUE TO VESSEL ANATOMY AND MODERATE CALCIFICATION OF THE COMMON EXTERNAL ILIAC. IN ORDER TO REPAIR THE DISSECTION, A PERIPHERAL OCCLUSION BALLOON WAS PLACED ABOVE THE DISSECTION, FROM THE RIGHT FEMORAL SYSTEM AND A PERIPHERAL BARE METAL STENT WAS PLACED AT THE AREA OF THE DISSECTION. THE PHYSICIAN REMOVED THE ILIAC OCCLUSION BALLOON AND TIED THE PRECLUDE SUTURES TO COMPLETE THE CASE. POST PROCEDURE, THE PATIENT WAS IN STABLE CONDITION. THE ILIAC DISSECTION WAS ATTRIBUTED TO THE DIFFICULTY THAT WAS ENCOUNTERED WHILE THE PHYSICIAN ATTEMPTED TO ADVANCE THE 24 FR SHEATH THROUGH THE PATIENT¿S CALCIFIED PORTION OF THE COMMON EXTERNAL ILIAC. THE PATIENT HAD A MINIMUM LUMINAL DIAMETER (MLD) OF 7.8 WITH MILD VESSEL CALCIFICATION AND MILD VESSEL TORTUOSITY, THERE WERE NO ABNORMALITIES NOTED WITH THE SHEATH AND/OR THE DILATORS PRIOR TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280296 RETROFLEX 3 INTRODUCER SHEATH SET INTRODUCER, CATHETER DYB EDWARDS LIFESCIENCES 9120S26

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention