BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EDWARDS LIFESCIENCES SHEATH

    MDR report key: 19426571 · Received May 30, 2024

    Report

    Report Number
    2015691-2024-04023
    Event Type
    Injury
    Date Received
    May 30, 2024
    Date of Event
    January 1, 2012
    Report Date
    June 17, 2024
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS ONE OF TWO MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. PLEASE REFERENCE RELATED MANUFACTURER REPORT NO: 2015691-2021-04017. 2015691-2021-04018. 2015691-2021-04019. 2015691-2021-04020. 2015691-2021-04021. 2015691-2021-04022 2015691-2021-04023. 2015691-2021-04024. 2015691-2021-04025.. 2015691-2021-04026.. 2015691-2021-04027.

    Additional Manufacturer Narrative · 0

    THIS IS ONE OF ELEVEN MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. THE DATES OF THE EVENTS ARE UNKNOWN; HOWEVER, ACCORDING TO THE ARTICLE THE STUDY PERIOD WAS BETWEEN JANUARY 2012 AND JUNE 2021. FOR THIS REASON, THE FIRST DAY OF THE REPORTED STUDY PERIOD (01 JANUARY 2012) WAS USED AS THE OCCURRENCE DATE.IN THIS CASE, THE EXACT VALVE MODEL NUMBER IS NOT AVAILABLE. THEREFORE, SECTIONS D1 AND D4 OF THIS REPORT WILL REFLECT AN UNKNOWN EDWARDS LIFESCIENCES SHEATH. THE POSSIBLE PMA/510K NUMBERS ASSOCIATED WITH AN UNKNOWN EDWARDS LIFESCIENCES SHEATH ARE: K093877 RETROFLEX 3TM INTRODUCER SHEATH SET - MODELS 9120S; P130009 EDWARDS EXPANDABLE INTRODUCER SHEATH SET - MODELS 916ES23, 918ES26, AND 920ES29; K200258 EDWARDS ESHEATH AND PLUS INTRODUCER SET(TRANSFEMORAL), MODELS 914ES AND 916ES REFERENCE ARTICLE OKUNO, TAISHI, ET AL. 5 YEAR OUTCOMES WITH SELFEXPANDING VS BALLOON EXPANDABLE TRANSCATHETER AORTIC VALVE REPLACEMENT IN PATIENTS WITH SMALL ANNULI. CARDIOVASCULAR INTERVENTIONS 16.4 (2023): 429440. PER THE INSTRUCTIONS FOR USE (IFU), CARDIOVASCULAR INJURIES SUCH AS PERFORATION OR DISSECTION OFVESSELS, VENTRICLE, MYOCARDIAL OR VALVULAR STRUCTURES ARE KNOWN POTENTIAL RISKS OR ADVERSE EVENTSASSOCIATED 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 INSERTIONWITH REGARDS TO PROPER SCREENING CRITICAL TO REDUCING VASCULAR COMPLICATIONS. THE TRAINING MANUAL INSTRUCTS THE OPERATOR ON PROPER SHEATH INSERTION AND WITHDRAWAL TECHNIQUES, INCLUDING PREDILATINGTHE VESSEL WITH THE EDWARDS DILATORS, AS NEEDED. IT ALSO NOTES THAT CALCIFICATION MAYREDUCE 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 VESSELSTHAT 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 ORTORTUOSITY, NOT ALWAYS APPRECIABLE ON IMAGING, COULD BE CONTRIBUTING FACTORS TO THE EVENT. IN THIS CASE, THERE WAS NOALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT.IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THISADVERSE EVENT. INVESTIGATION RESULTS SUGGEST, BASED ON THE LIMITED INFORMATION PROVIDED BY THE ARTICLE, A CAUSE COULD NOT BE DETERMINED. A REVIEW OF EDWARDS LIFESCIENCES RISK MANAGEMENT DOCUMENTATION WAS PERFORMED FOR THIS CASE. THE REPORTED EVENT IS AN ANTICIPATED RISK OF THE TRANSCATHETER HEART VALVEPROCEDURE, 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 THEDIRECTIONS 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 THECONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. AS SUCH, NEITHER APRODUCT RISK ASSESSMENT, NOR CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    AS REPORTED BY AN EDWARDS LIFESCIENCES AFFILIATE IN SWITZERLAND, THROUGH REVIEW OF MEDICAL ARTICLE 5 YEAR OUTCOMES WITH SELF EXPANDING VS BALLOON EXPANDABLE TRANSCATHETER AORTIC VALVE REPLACEMENT IN PATIENTS WITH SMALL ANNULI, CORRESPONDING AUTHOR THOMAS PILGRIM, THE FOLLOWING EVENT(S) WAS/WERE IDENTIFIED AS PERTAINING TO AN EDWARDS DEVICE. ALL PATIENTS UNDERGOING TAVR AT BERN UNIVERSITY HOSPITAL. THE PRESENT ANALYSIS INCLUDED CONSECUTIVE PATIENTS WITH AN AORTIC VALVE ANNULUS AREA LESS THAN 430 MM2 WHO UNDERWENT TRANSFEMORAL TAVR WITH EITHER A MEDTRONIC SELF EXPANDING (SUPRA ANNULAR) THV OR AN EDWARDS BALLOON EXPANDABLE (INTRA ANNULAR) THV BETWEEN JANUARY 2012 AND JUNE 2021. THERE WERE 14 PATIENTS WITH AN UNKNOWN SAPIEN VALVE IMPLANTED HAD MAJOR VASCULAR COMPLICATIONS DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1234390 UNKNOWN EDWARDS LIFESCIENCES SHEATH INTRODUCER, CATHETER DYB EDWARDS LIFESCIENCES UNKNOWN EDWARDS LIFESCIENCES SHEATH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention