BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    EDWARDS ESHEATH INTRODUCER SHEATH

    MDR report key: 11976347 · Received June 10, 2021

    Report

    Report Number
    2015691-2021-03439
    Event Type
    Injury
    Date Received
    June 10, 2021
    Date of Event
    January 1, 2021
    Report Date
    June 10, 2021
    Manufacturer
    EDWARDS LIFESCIENCES
    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 · 1

    THIS REPORT PROVIDES DATA FROM THV/TVT REGISTRY EXEMPTION NUMBER (B)(4) E2016006 AND SUMMARIZES 3 BLEEDING AT ACCESS SITE SERIOUS INJURY EVENTS FOR THE SAPIEN 3 TRANSCATHETER HEART VALVE IN THE MITRAL POSITION. THE 'TIME TO EVENT' (TTE, IN DAYS) FOR THIS EVENT WAS 0.0. THE DEVICE IDENTIFICATION (DI) NUMBERS FOR EDWARDS ESHEATH INTRODUCER SET ARE 00690103193985, 00690103193992. THE INSTRUCTIONS FOR USE (IFU) LIST HEMORRHAGE REQUIRING TRANSFUSION OR INTERVENTION AS A POTENTIAL RISK ASSOCIATED WITH THE OVERALL TAVR PROCEDURE, INCLUDING POTENTIAL ACCESS COMPLICATIONS ASSOCIATED WITH STANDARD CARDIAC CATHETERIZATION. THE MAJORITY OF TRANSFEMORAL ACCESS RELATED BLEEDING COMPLICATIONS ARE RELATED TO DISEASED ILEO-FEMORAL VESSELS AND/OR PROCEDURAL TECHNIQUE DURING THE INSERTION OR REMOVAL OF THE SHEATH AND/OR DILATORS. THERE ARE CASES WHERE THE BLEEDING IS SIGNIFICANT AND MORE COMPLEX INTERVENTION OR TRANSFUSION IS REQUIRED TO TREAT/PREVENT A PERMANENT INJURY FROM OCCURRING. THE THV PHYSICIAN TRAINING MANUALS INSTRUCT ON PROCEDURAL CONSIDERATIONS FOR SHEATH INSERTION WITH REGARDS TO PROPER SCREENING CRITICAL TO REDUCING VASCULAR COMPLICATIONS. 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 VALVE CAN BE DELIVERED TRANSFEMORALLY. 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; HOWEVER, A TRANSFUSION OF 2 UNITS OR MORE OF BLOOD WAS REPORTED IN THE REGISTRY. BY VARC DEFINITION, THE MEET CRITERIA FOR MAJOR VASCULAR COMPLICATION; THEREFORE, THE EVENT IS BEING REPORTED. 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 SERIOUS INJURIES FOR THE SAPIEN 3 VALVE. THIS REPORT SUMMARIZES 3 BLEEDING AT ACCESS SITE SERIOUS INJURY EVENTS FOR THE SAPIEN 3 TRANSCATHETER HEART VALVE. THE AGE RANGE FOR THESE EVENTS IS 72-86 YEARS. THE BREAKDOWN FOR GENDER IS AS FOLLOWS: 2 FEMALES AND 1 MALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    871861 EDWARDS ESHEATH INTRODUCER SHEATH PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED NPU EDWARDS LIFESCIENCES ESHEATH UNKNOWN N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other