BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS ESHEATH INTRODUCER SHEATH

    MDR report key: 18862521 · Received March 7, 2024

    Report

    Report Number
    2015691-2024-01906
    Event Type
    Injury
    Date Received
    March 7, 2024
    Date of Event
    February 1, 2020
    Report Date
    March 8, 2024
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYB
    PMA / PMN Number
    K200258
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BIBLIOGRAPHY: CHAVARRIA, JORGE, ET AL. 'BESPOKE VALVE SIZING AVOIDS ANNULAR RUPTURE IN PATIENTS TREATED WITH A BALLOON-EXPANDABLE TRANSCATHETER HEART VALVE.' CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 100.5 (2022): 823-831. THIS REPORT IS 2 OF 4 BEING SUBMITTED FOR THIS COMPLAINT. REFERENCE MFG. REPORT NO. 2015691-2024-01609, 2015691-2024-01613 AND 2015691-2024-01615. PER THE INSTRUCTIONS FOR USE (IFU), CARDIOVASCULAR INJURIES SUCH AS PERFORATION OR DISSECTION OF VESSELS, VENTRICLE, MYOCARDIAL OR VALVULAR STRUCTURES ARE KNOWN POTENTIAL RISKS OR ADVERSE EVENTS ASSOCIATED WITH THE OVERALL THV PROCEDURE AND MAY REQUIRE INTERVENTION. ACCORDING TO THE LITERATURE REVIEW, AND AS DOCUMENTED IN A TECHNICAL SUMMARY WRITTEN BY EW, VASCULAR COMPLICATIONS ARE A WELL-RECOGNIZED COMPLICATION OF THE TRANSFEMORAL THV 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 THE 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. PREPROCEDURE 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 WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. OTHER POTENTIAL CONTRIBUTING FACTORS ARE UNKNOWN AS LIMITED CLINICAL INFORMATION WAS PROVIDED. A REVIEW OF EDWARDS LIFESCIENCES RISK MANAGEMENT DOCUMENTATION WAS PERFORMED FOR THIS CASE. THE REPORTED EVENT IS AN ANTICIPATED RISK OF THE TRANSCATHETER HEART VALVE PROCEDURE, ADDITIONAL ASSESSMENT OF THIS ADVERSE EVENT IS NOT REQUIRED AT THIS TIME. 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 MONTHLY, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. AS SUCH, NEITHER A PRODUCT RISK ASSESSMENT, NOR CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME. H3 OTHER TEXT : NO DEVICE WILL BE RETURNED.

    Description of Event or Problem · 0

    A SINGLE-CENTER STUDY REPORTED THROUGH A EUROPEAN ARTICLE, 'BESPOKE VALVE SIZING AVOIDS ANNULAR RUPTURE IN PATIENTS TREATED WITH A BALLOON-EXPANDABLE TRANSCATHETER HEART VALVE'. THE STUDY WAS BETWEEN FEBRUARY 2020 TO FEBRUARY 2022 DURING WHICH ALL PATIENTS UNDERGOING TAVR AT OUR CENTER WERE TREATED WITH A SAPIEN 3 OR A SAPIEN 3 ULTRA VALVE. ALL PATIENTS UNDERWENT PRE-TAVR COMPUTED TOMOGRAPHY (CT) EVALUATION INCLUDING ANNULAR AND LVOT DIMENSIONS AND MEASUREMENT OF ANNULAR AND LVOT CALCIFICATION. THIS COMPLAINT IS FOR TEN PATIENTS WITH AN UNKNOWN EDWARDS SAPIEN 3 VALVE IMPLANTED IN THE AORTIC POSITION PRESENTED WITH MAJOR VASCULAR COMPLICATIONS AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITHIN 30 DAYS AFTER PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2162825 EDWARDS ESHEATH INTRODUCER SHEATH AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED DYB EDWARDS LIFESCIENCES ESHEATH UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention