BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS EXPANDABLE INTRODUCER SHEATH SET

    MDR report key: 4481458 · Received February 3, 2015

    Report

    Report Number
    2015691-2015-00224
    Event Type
    Injury
    Date Received
    February 3, 2015
    Date of Event
    January 13, 2015
    Report Date
    January 13, 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 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 XT 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 16 FR SHEATH IS 6.0 MM. THE PATIENT¿S ACCESS VESSEL MLD WAS REPORTED TO MEASURE 5.8MM WITH NO CALCIFICATION OR TORTUOSITY. IN THIS CASE, IT APPEARS THAT PATIENT FACTORS (ACCESS VESSEL DIAMETER SMALLER THAN MINIMUM REQUIREMENTS) LIKELY CONTRIBUTED TO THE FEMORAL ARTERY DISSECTION. THERE WAS NO ALLEGATION OR INDICATION OF A DEVICE MALFUNCTION. 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

    AS REPORTED BY OUR (B)(4) AFFILIATE, A FEMORAL ARTERY DISSECTION WAS OBSERVED UPON REMOVAL OF THE 16 FR ESHEATH. DURING A TF TAVR PROCEDURE, PERCUTANEOUS PUNCTURE ACCESS WAS OBTAINED. A16FR DILATOR AND ESHEATH WERE INSERTED WITHOUT RESISTANCE. A DELIVERY SYSTEM WAS INSERTED WITHOUT RESISTANCE OTHER THAN USUAL, AND THE SAPIEN XT VALVE WAS SUCCESSFULLY DEPLOYED. WHILE REMOVING THE ESHEATH, THE DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) SHOWED A DISSECTION SLIGHTLY ABOVE THE PUNCTURE SITE. THE DISSECTION WAS REPAIRED BY IMPLANTING A STENT. SINCE THE DISTAL END OF THE STENT WAS VERY CLOSE TO THE INGUINAL LIGAMENT, THE STENT WAS POST DILATED WITH A BALLOON. BALLOON INFLATION WAS PERFORMED FOR 4 SECONDS AT 6ATM EACH IN THE PROXIMAL AND DISTAL END OF THE STENT. THE PUNCTURE SITE WAS CLOSED WITH PERCLOSE PROGLIDE AND THE PROCEDURE WAS FINISHED. THE OPERATOR COMMENTED THAT IT WAS UNKNOWN IF THE DISSECTION WAS CAUSED BY THE ESHEATH. THE PATIENT¿S ACCESS VESSEL MINIMUM LUMINAL DIAMETER (MLD) MEASURED 5.8 MM WITH NO CALCIFICATION AND NO TORTUOSITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78762 EDWARDS EXPANDABLE INTRODUCER SHEATH SET AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 916ES23J 59772375

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Required Intervention