BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS EXPANDABLE INTRODUCER SHEATH

    MDR report key: 4905512 · Received July 10, 2015

    Report

    Report Number
    2015691-2015-01642
    Event Type
    Injury
    Date Received
    July 10, 2015
    Date of Event
    June 18, 2015
    Report Date
    June 18, 2015
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    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 CLINICAL 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, AS NEEDED. 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 SHEATH IS 6.5MM. IN THIS CASE, THE PATIENT¿S ACCESS VESSEL MLD WAS 5.5MM X 6.3MM WITH MODERATE CALCIFICATION AND MILD TORTUOSITY NOTED. A SIGNIFICANT AREA OF CALCIFICATION WAS NOTED IN THE EIA. IT IS POSSIBLE THAT PATIENT FACTORS (LESS THAN ADEQUATE ASSESS VESSEL MLD, MODERATE CALCIFICATION AND AN AREA OF SIGNIFICANT CALCIFICATION IN THE EIA) LIKELY 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.

    Description of Event or Problem · 1

    DURING THE TRANSFEMORAL TAVR PROCEDURE, RIGHT FEMORAL ARTY ACCESS WAS OBTAINED. SERIAL DILATION UP TO THE 20FR DILATOR WAS PERFORMED AND AN 18FR EXPANDABLE SHEATH (ESHEATH) WAS INSERTED. A 26MM SAPIEN XT VALVE AND NOVAFLEX+ DELIVERY SYSTEM WERE INSERTED, BUT WERE UNABLE TO BE ADVANCED THROUGH THE ESHEATH. THE PROCEDURE WAS STOPPED AND THE ESHEATH, VALVE AND DELIVERY SYSTEM WERE REMOVED. A REVIEW OF THE CT SCAN INDICATED AN AREA OF SIGNIFICANT CALCIFICATION IN THE EXTERNAL ILIAC ARTERY (EIA) NOT PREVIOUSLY NOTED. THE DECISION WAS MADE TO CONVERT THE PROCEDURE TO A COREVALVE. A 19FR SOLOPATH SHEATH WAS INSERTED AND A COREVALVE WAS IMPLANTED. AT THE END OF THE CASE, A SIGNIFICANT VASCULAR INJURY WAS NOTED, REQUIRING OPEN SURGICAL REPAIR. THE VESSEL APPEARED TO BE OKAY FOLLOWING REMOVAL OF THE ESHEATH; HOWEVER, THE EXACT TIMING OF THE INJURY CANNOT BE CONFIRMED. IT WAS PERCEIVED THAT PATIENT FACTORS, ACCESS VESSEL MINIMUM LUMINAL DIAMETER (MLD) AND CALCIFICATION, LIKELY CONTRIBUTED TO THE VASCULAR INJURY. IT CANNOT BE CONFIRMED IF THE INJURY WAS THE RESULT OF THE ESHEATH OR THE SOLOPATH SHEATH. THE ACCESS VESSEL MLD WAS 5.5MM X 6.3MM (EIA) WITH MODERATE CALCIFICATION AND MILD TORTUOSITY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449742 EDWARDS EXPANDABLE INTRODUCER SHEATH AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 918ES26 60038684

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Required Intervention