BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS TRANSFEMORAL ESHEATH

    MDR report key: 11971483 · Received June 9, 2021

    Report

    Report Number
    2015691-2021-03400
    Event Type
    Death
    Date Received
    June 9, 2021
    Date of Event
    January 1, 2021
    Report Date
    June 10, 2021
    Manufacturer
    EDWARDS LIFESCIENCES LLC
    Product Code
    NPU
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT PROVIDES DATA FROM THV/TVT REGISTRY EXEMPTION NUMBER E2016006 AND SUMMARIZES 1 EVENT OF MAJOR VASCULAR COMPLICATION DEATH FOR THE SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE IN THE MITRAL POSITION. THE 'TIME TO EVENT' (TTE, IN DAYS) FOR THIS EVENT WAS 18.

    Additional Manufacturer Narrative · 1

    THIS REPORT PROVIDES DATA FROM THV/TVT REGISTRY EXEMPTION NUMBER E2016006 AND SUMMARIZES 1 EVENT OF MAJOR VASCULAR COMPLICATION FOR THE EDWARDS TF SHEATH UNKNOWN IN THE MITRAL POSITION. THE 'TIME TO EVENT' (TTE, IN DAYS) FOR THIS EVENT WAS 6. DUE TO THE LIMITED INFORMATION AND THE DATA RECEIVED, EDWARDS CANNOT CONFIRM WHICH ESHEATH WAS USED IN THIS CASE, THE AXELA OR ESHEATH INTRODUCER SET. THE UDI FOR BOTH DEVICES ARE REFERENCED BELOW. THE DEVICE IDENTIFICATION (DI) NUMBERS FOR EDWARDS AXELA SHEATH IS (B)(4). THE DEVICE IDENTIFICATION (DI) NUMBERS FOR EDWARDS ESHEATH INTRODUCER SET ARE (B)(4). 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 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 TVR 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 VESSEL CHARACTERISTICS THAT WOULD PRECLUDE SAFE PLACEMENT OF SHEATHS SUCH AS SEVERE OBSTRUCTIVE CALCIFICATION OR SEVERE TORTUOSITY. PRE-PROCEDURE SCREENING AND ASSESSMENT OF THE VASCULAR INTERNAL DIAMETERS WILL ENABLE THE CLINICIAN TO DETERMINE IF THE THV CAN BE DELIVERED THROUGH THE PLANNED ACCESS SITE. 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 VESSELS THAT ARE NOT AMENABLE TO PERCUTANEOUS VALVE DELIVERY 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, SPECIFIC PROCEDURAL DETAILS ARE NOT AVAILABLE TO DETERMINE POTENTIAL CONTRIBUTING FACTORS TO THE EVENT, OR IF THE EVENT IS RELATED TO AN EDWARDS DEVICE. 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.

    Description of Event or Problem · 1

    THV/TVT REGISTRY SUMMARY REPORTING FOR ADVERSE EVENT SUBMISSION FOR QUARTER 1 2021 DATA EXTRACT FOR MITRAL DEATHS FOR THE SAPIEN 3 ULTRA VALVE. THIS REPORT SUMMARIZES 1 MAJOR VASCULAR COMPLICATION EVENT FOR THE SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868120 EDWARDS TRANSFEMORAL ESHEATH PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED NPU EDWARDS LIFESCIENCES LLC TF SHEATH UNKNOWN N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death