BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS TRANSCATHETER TRANSFEMORAL SHEATH

    MDR report key: 9548972 · Received January 3, 2020

    Report

    Report Number
    2015691-2020-10024
    Event Type
    Injury
    Date Received
    January 3, 2020
    Date of Event
    September 1, 2008
    Report Date
    December 12, 2019
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE CAPA-20-00141.

    Additional Manufacturer Narrative · 1

    THE SPECIFIC SHEATH MODEL AND SIZE IS UNKNOWN. EDWARDS RETROFLEX 3 INTRODUCER SHEATH PMA K09387, EDWARDS EXPANDABLE INTRODUCER 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 DIAMETERS FOR A 22FR. AND 24FR. RETROFLEX 3 INTRODUCER SHEATH ARE >7MM AND >8MM RESPECTIVELY. THE MINIMUM REQUIRED VESSEL DIAMETERS FOR A 16FR, 18FR. AND 20FR. EXPANDABLE INTRODUCER SHEATH ARE 6.0MM, 6.5MM AND 7.0MM RESPECTIVELY. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. INVESTIGATION RESULTS SUGGEST/INDICATE PROCEDURAL FACTORS (MANIPULATION OF THE DEVICES), IN ADDITION TO PATIENT FACTORS (FRAGILE VESSEL) LIKELY CONTRIBUTED TO THE VASCULAR COMPLICATION AND SUBSEQUENT ILIAC-FEMORAL BYPASS GRAFTING. 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: GENNARI, M., TRABATTONI, P., PEPI, M., POLVANI, G., SALVI, L., AGRIFOGLIO, M. TRANS-ILIAC AORTIC VALVE REPLACEMENT: FEASIBILITY, SAFETY, AND MEDIUM-TERM FOLLOW-UP. JOURNAL OF CARDIOVASCULAR SURGERY (2019). HTTPS://JOURNALS.SAGEPUB.COM/DOI/PDF/10.1177/1179065219853582.

    Description of Event or Problem · 1

    AS REPORTED BY OUR AFFILIATE IN (B)(6) AND THROUGH AN ARTICLE, ¿TRANS-ILIAC AORTIC VALVE REPLACEMENT: FEASIBILITY, SAFETY, AND MEDIUM-TERM FOLLOW-UP¿, FROM SEPTEMBER 2008 TO JUNE 2014, 440 PATIENTS UNDERWENT TAVR PROCEDURES AT THE REPORTING INSTITUTION. TWELVE (12) PATIENTS RECEIVED SAPIEN 3 OR SAPIEN XT VALVES BY SURGICAL TRANS-ILIAC APPROACH USING THE RETROFLEX AND NOVAFLEX SHEATHS. THE TRANS-ILIAC ROUTE WAS SELECTED WHENEVER THE FEMORAL ARTERIES WERE TOO SMALL, HIGH, OR CALCIFIED AND THERE IS MODERATE TORTUOSITY OF THE ILIAC AXES IN THE ABSENCE OF CIRCUMFERENTIAL CALCIFICATION. A ¿MAJOR¿ LOCAL VASCULAR ACCESS COMPLICATION OCCURRED IN ONE PATIENT. THE LACERATION OF A VERY FRAGILE VESSEL AT THE REMOVAL OF THE SHEATH WAS REPORTED. AN ILIAC-FEMORAL BYPASS GRAFTING BY MEANS OF A VASCULAR PROSTHESIS WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5138 EDWARDS TRANSCATHETER TRANSFEMORAL SHEATH AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES TF SHEATH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention