BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS EXPANDABLE INTRODUCER SHEATH

    MDR report key: 4223397 · Received November 4, 2014

    Report

    Report Number
    2015691-2014-02605
    Event Type
    Injury
    Date Received
    November 4, 2014
    Date of Event
    October 15, 2014
    Report Date
    October 15, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT 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 AN 18FR ESHEATH IS 6.5MM. IN THIS CASE, THE PATIENT¿S ACCESS VESSEL MLD WAS 9.1MM X 9.6MM, WITH MILD CALCIFICATION AND MODERATE TORTUOSITY. THE CAUSE OF THE INTIMAL TEAR CANNOT BE CONFIRMED. HOWEVER, IT IS LIKELY THAT THE MILD CALCIFICATION AND MODERATE TORTUOSITY CONTRIBUTED TO THIS 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. THIS IS ONE OF TWO MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE.

    Additional Manufacturer Narrative · 1

    PLEASE REFERENCE RELATED MANUFACTURER REPORT NO: 2015691-2014-02628.

    Description of Event or Problem · 1

    DURING THE TRANSFEMORAL (TF) TAVR PROCEDURE, AN INTIMAL TEAR WAS NOTED IN THE ILIAC ARTERY, REQUIRING SURGICAL REPAIR. INITIALLY, THE EXPANDABLE SHEATH (ESHEATH) WAS INSERTED INTO THE LEFT COMMON FEMORAL ARTERY. THE NOVAFLEX+ (NF+) DELIVERY SYSTEM (DS) WAS INSERTED AND ADVANCED. WHEN THE DS WAS ABOUT 2 INCHES ABOVE THE TIP OF THE EXPANDABLE SHEATH (ESHEATH), THE PATIENT BECAME HYPOTENSIVE. A 4CM THORACIC ANEURYSM RUPTURED AT THE LEVEL OF THE TRANSVERSE AORTA. THE TF PROCEDURE WAS ABORTED PRIOR TO THE DEPLOYMENT OF A 26MM SAPIEN XT VALVE. THE PATIENT WAS PLACED ON BYPASS AND THE RUPTURED ANEURYSM WAS REPAIRED. ONCE THE REPAIR WAS COMPLETED, THE DS AND ESHEATH WERE REMOVED FROM THE FEMORAL ARTERY. FOLLOWING ESHEATH REMOVAL, AN INTIMAL TEAR IN THE ILIAC ARTERY WAS NOTED AND SURGICALLY REPAIRED. WHILE THE PATIENT WAS STILL ON BYPASS, THE TAVR PROCEDURE WAS CONVERTED TO THE TRANSAPICAL (TA) APPROACH. A 26MM SAPIEN XT VALVE WAS POSITIONED AND DEPLOYED WITHOUT ANY ISSUES AND THE ACCESS SITE WAS PARTIALLY CLOSED. THE PATIENT WAS NOT ABLE TO COME OFF OF BYPASS AND EXPIRED DURING THE PROCEDURE. THE ACCESS VESSEL MINIMUM LUMINAL DIAMETER (MLD) WAS 9.1MM X 9.6MM, WITH MILD CALCIFICATION AND MODERATE TORTUOSITY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707519 EDWARDS EXPANDABLE INTRODUCER SHEATH AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 918ES26 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention