BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS TRANSCATHETER TF SHEATH

    MDR report key: 8090388 · Received November 20, 2018

    Report

    Report Number
    2015691-2018-04803
    Event Type
    Injury
    Date Received
    November 20, 2018
    Date of Event
    November 1, 2009
    Report Date
    October 24, 2018
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXACT DATES OF THE REPORTED EVENTS ARE UNKNOWN. PER THE AUTHORS, THE FIRST TAVR WAS PERFORMED IN (B)(6) 2009; THEREFORE, (B)(6) 2009 HAVE BEEN SELECTED AS THE OCCURRENCE DATE. THE EXACT DEVICES USED FOR THE REPORTED EVENTS ARE UNKNOWN. POSSIBLE DEVICE USED ¿ EDWARDS RETROFLEX INTRODUCER SHEATH SET ¿ PMA K093877, EDWARDS EXPANDABLE INTRODUCER SHEATH SET ¿ PMA P130009, EDWARDS ASCENDRA+ INTRODUCER SHEATH SET ¿ PMA P130009, OR EDWARDS ESHEATH INTRODUCER SET ¿ PMA P140031.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: F10, H6. REFERENCE CAPA-20-00141.

    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 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. IN THIS CASE, THERE IS INSUFFICIENT INFORMATION TO DETERMINE THE CAUSE OF THE REPORTED MAJOR VASCULAR COMPLICATIONS. THE AUTHORS DID NOT SPECIFY TO WHICH OF THE DEVICES USED DURING THE TAVR PROCEDURE THESE EVENTS WERE ASSOCIATED. 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. REFERENCE FOR ARTICLE: LAREYRE, F., RAFFORT, J., DOMMERC, C., HABIB, Y., BOURLON, F., MIALHE, C. (2017). A 7-YEAR SINGLE-CENTER EXPERIENCE OF TRANSFEMORAL TAVI: EVOLUTION OF SURGICAL ACTIVITY AND IMPACT ON VASCULAR OUTCOME. SAGE JOURNALS. RETRIEVED FROM: HTTPS://JOURNALS.SAGEPUB.COM/DOI/ABS/10.1177/0003319717737665 THIS IS ONE OF TWO MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. PLEASE REFERENCE RELATED MANUFACTURER REPORT NO: 2015691-2018-04784.

    Description of Event or Problem · 1

    AS REPORTED BY OUR AFFILIATE IN (B)(6) AND THROUGH AN LITERATURE ARTICLE, ¿A 7-YEAR SINGLE-CENTER EXPERIENCE OF TRANSFEMORAL TAVI: EVOLUTION OF SURGICAL ACTIVITY AND IMPACT ON VASCULAR OUTCOME¿, 340 PATIENTS WITH SEVERE SYMPTOMATIC AORTIC STENOSIS WHO UNDERWENT TRANSFEMORAL TAVI WITH EDWARDS SAPIEN VALVES FROM NOVEMBER 2009 TO APRIL 2017 WERE RETROSPECTIVELY INCLUDED IN A 7 YEARS SINGLE-CENTER STUDY. 30 DAYS POST-OPERATIVE MORTALITY WAS RECORDED AND VASCULAR COMPLICATIONS WERE EVALUATED ACCORDING TO VALVE ACADEMIC RESEARCH CONSORTIUM-2, VERSION 2012. DURING THE STUDY PERIOD, 6 PATIENTS SUFFERED ¿MAJOR ACCESS SITE OR ACCESS-RELATED VASCULAR INJURIES¿. INFORMATION REGARDING THE INJURIES AND TREATMENT GIVEN WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    931621 EDWARDS TRANSCATHETER TF SHEATH AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES TF SHEATH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention