BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS TRANSCATHETER INTRODUCER SHEATH

    MDR report key: 10997904 · Received December 13, 2020

    Report

    Report Number
    2015691-2020-14999
    Event Type
    Injury
    Date Received
    December 13, 2020
    Date of Event
    January 1, 2008
    Report Date
    November 19, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TRANSFEMORAL TRANSCATHETER SHEATHS USED ARE UNKNOWN. POSSIBLE SHEATHS USED ¿ EDWARDS RETROFLEX 3 SHEATH ¿ PMA P110021, OR THE EDWARDS EXPANDABLE SHEATH ¿ PMA P130009. 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 MINIMUM REQUIRED VESSEL 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, AND THE REQUIRED MLD FOR A 20FR EXPANDABLE SHEATH IS 7.0MM. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. BASED ON THE INFORMATION AVAILABLE, THE EXACT CAUSE OF THE VASCULAR COMPLICATIONS CANNOT BE CONFIRMED. INVESTIGATION RESULTS SUGGEST/INDICATE IN ADDITION TO PROCEDURAL FACTORS (MANIPULATION OF THE DEVICES), PATIENT FACTORS (ACCESS VESSEL MLD, CALCIFICATION, TORTUOSITY) MAY HAVE CONTRIBUTED TO THE VASCULAR INJURIES AND SUBSEQUENT COVERED STENT PLACEMENTS. 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: BEN ABDALLAH I, URENA M, SUTTER W, BEZARD C, PELLENC Q, CERCEAU P, NGUYEN TH, HIMBERT D, CASTIER Y. COVERED STENTS AS A FIRST-LINE TREATMENT FOR VASCULAR ACCESS COMPLICATIONS DURING TRANSFEMORAL TRANSCATHETER AORTIC VALVE IMPLANTATION: EIGHT-YEAR EXPERIENCE FROM A SINGLE CENTER. ANGIOLOGY. 2021 JAN;72(1):70-77. DOI: 10.1177/0003319720950148. EPUB 2020 AUG 19. PMID: 32812435. HTTPS://PUBMED.NCBI.NLM.NIH.GOV/32812435/. THIS IS ONE OF TWO MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. PLEASE REFERENCE RELATED MANUFACTURER REPORT NO: 2015691-2020-14988.

    Description of Event or Problem · 1

    AS REPORTED BY OUR AFFILIATE IN (B)(6) AND THROUGH AN ARTICLE, ¿COVERED STENTS AS A FIRST-LINE TREATMENT FOR VASCULAR ACCESS COMPLICATIONS DURING TRANSFEMORAL TRANSCATHETER AORTIC VALVE IMPLANTATION: EIGHT-YEAR EXPERIENCE FROM A SINGLE CENTER¿, 74 PATIENTS, FROM A SINGLE CENTER, WHO UNDERWENT PERCUTANEOUS TRANSFEMORAL TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) FROM JANUARY 2008 TO JANUARY 2018, HAD MINOR OR MAJOR VASCULAR ACCESS COMPLICATIONS (VAC). FROM THESE PATIENTS, 43 WERE IMPLANTED SAPIEN OR SAPIEN XT VALVES. VASCULAR COMPLICATIONS REQUIRING OPEN SURGICAL REPAIR, OCCURRED IN 9 STUDY PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1464620 EDWARDS TRANSCATHETER INTRODUCER SHEATH AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES TF SHEATH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention