BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    EDWARDS ESHEATH INTRODUCER SET

    MDR report key: 12939017 · Received December 6, 2021

    Report

    Report Number
    2015691-2021-06703
    Event Type
    Injury
    Date Received
    December 6, 2021
    Report Date
    December 6, 2021
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE TRANSFEMORAL INTRODUCER SHEATH MODEL AND SIZE IS UNKNOWN. POSSIBLE SHEATH USED - THE EDWARDS RETROFLEX 3TM INTRODUCER SHEATH SET - PMA K093554, OR THE EDWARDS EXPANDABLE INTRODUCER SHEATH SET - PMA P130009, OR THE EDWARDS ESHEATH INTRODUCER SET - PMA P140031. 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 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 REQUIRED VESSEL MINIMUM LUMEN DIAMETER (MLD) FOR A 22FR RETROFLEX 3 SHEATH IS 7MM, THE REQUIRED MLD FOR A 24FR RETROFLEX 3 SHEATH IS 8MM, THE REQUIRED MLD FOR A 16FR EXPANDABLE SHEATH IS 6.0MM, THE REQUIRED MLD FOR AN 18FR EXPANDABLE SHEATH IS 6.5MM, THE REQUIRED MLD FOR A 20FR EXPANDABLE SHEATH IS 7.0MM, THE REQUIRED MLD FOR A 14FR ESHEATH IS 5.5MM, AND THE REQUIRED MLD FOR AN 18FR ESHEATH IS 6.0MM. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. INVESTIGATION RESULTS SUGGEST IN ADDITION TO PROCEDURAL FACTORS (MANIPULATION OF THE DEVICES), PATIENT FACTORS NOT PROVIDED MAY HAVE CONTRIBUTED TO THE REPORTED VASCULAR COMPLICATIONS. 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 · 0

    AS REPORTED BY OUR AFFILIATE IN (B)(6) AND THROUGH AN ARTICLE, 'COMPARISON OF LATEST GENERATION SUPRA-ANNULAR AND INTRA-ANNULAR SELF-EXPANDING TRANSCATHETER HEART VALVES', A SINGLE CENTER STUDY WAS PERFORMED. BETWEEN JANUARY 2014 AND JULY 2019. 1.561 PATIENTS UNDERWENT A TRANSFEMORAL TAVI FOR SEVERE NATIVE AORTIC VALVE STENOSIS. OF THESE, 78 PATIENTS RECEIVED AN EDWARDS CENTERA HEART VALVE. AS REPORTED, MAJOR VASCULAR COMPLICATIONS OCCURRED IN 8 PATIENTS WHO RECEIVED THE EDWARDS VALVE. INFORMATION REGARDING THE TYPE OF VASCULAR COMPLICATIONS AND THE POSSIBLE ACTIONS TAKEN WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1837417 EDWARDS ESHEATH INTRODUCER SET AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES ESHEATH UNKNOWN N/I

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other