BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS EXPANDABLE INTRODUCER SHEATH SET

    MDR report key: 4635053 · Received March 26, 2015

    Report

    Report Number
    2015691-2015-00699
    Event Type
    Injury
    Date Received
    March 26, 2015
    Date of Event
    March 6, 2015
    Report Date
    March 6, 2015
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE. ACCORDING TO LITERATURE REVIEW, AND AS DOCUMENTED BY EDWARDS IN A TECHNICAL SUMMARY, VASCULAR COMPLICATIONS ARE A WELL RECOGNIZED COMPLICATION OF THE 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 VESSEL CHARACTERISTICS THAT WOULD PRECLUDE SAFE PLACEMENT OF SHEATHS SUCH AS SEVERE OBSTRUCTIVE CALCIFICATION OR SEVERE TORTUOSITY. PRE-PROCEDURE SCREENING AND ASSESSMENT OF THE ACCESS VESSEL INTERNAL DIAMETERS WILL ENABLE THE CLINICIAN TO DETERMINE IF THE SAPIEN VALVE CAN BE DELIVERED. 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 ACCESS VESSELS THAT ARE NOT AMENABLE TO THE 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 FOLLOWING GUIDANCE IS PROVIDED FOR SHEATH REMOVAL: ¿REMOVE THE ESHEATH ENTIRELY WITHOUT TORQUING ENSURING THE EDWARDS LOGO IS FACING UPWARDS¿. THE MINIMUM REQUIRED VESSEL DIAMETER FOR A 16FR SHEATH IS 6.0 MM. IN THIS CASE, THE ACCESS VESSEL MINIMUM LUMINAL DIAMETER WAS 6.0 MM. THE BORDERLINE VESSEL DIAMETER APPEARS TO HAVE CONTRIBUTED TO THE DISSECTION. 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

    IT WAS REPORTED BY OUR (B)(6) AFFILIATE THAT DURING A TRANSFEMORAL TAVR PROCEDURE, A DISSECTION OF THE RIGHT FEMORAL ARTERY OCCURRED. ACCESS WAS OBTAINED ON THE RIGHT FEMORAL ARTERY VIA A SURGICAL CUTDOWN. WHEN A 16FR DILATOR AND SUBSEQUENT 16FR ESHEATH WERE INSERTED NO RESISTANCE WAS FELT. HOWEVER, WHEN THE DELIVERY SYSTEM PASSED THROUGH THE SHEATH, RESISTANCE WAS FELT. A SAPIEN XT VALVE WAS ABLE TO BE SUCCESSFULLY IMPLANTED. FOLLOWING REMOVAL OF THE SHEATH, DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) SHOWED A DISSECTION IN THE RIGHT FEMORAL ARTERY. THE DISSECTION WAS REPAIRED WITH STENT PLACEMENT. THE PATIENT LEFT THE OPERATING ROOM WITHOUT ANY PROBLEM THEREAFTER. THE MINIMUM LUMINAL DIAMETER OF THE ACCESS VESSEL WAS 6.0 MM. THE VESSEL CALCIFICATION WAS REPORTED TO BE MILD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201648 EDWARDS EXPANDABLE INTRODUCER SHEATH SET AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 916ES23J 59977845

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention