BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS ESHEATH INTRODUCER SET

    MDR report key: 20478313 · Received October 18, 2024

    Report

    Report Number
    2015691-2024-07934
    Event Type
    Injury
    Date Received
    October 18, 2024
    Date of Event
    March 30, 2023
    Report Date
    November 11, 2024
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYB
    PMA / PMN Number
    K200258
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED SECTION E1 TELEPHONE NUMBER.

    Additional Manufacturer Narrative · 0

    ARTICLE REFERENCE: CARANDE, E. J., SALIM, T. S., CHASE, A., SEKAR, B., ALDALATI, O., HAILAN, A., KHURANA, A., SMITH, D., & OBAID, D. R. (2023). COMPUTED TOMOGRAPHY DEFINED FEMORAL ARTERY PLAQUE COMPOSITION PREDICTS VASCULAR COMPLICATIONS DURING TRANSCATHETER AORTIC VALVE IMPLANTATION. THE BRITISH JOURNAL OF RADIOLOGY, 96(1152), 20230296. PER THE INSTRUCTIONS FOR USE (IFU), THROMBOSIS AND EMBOLIZATION OF AIR, CALCIFICATION OR THROMBUS ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH TRANSCATHETER AORTIC VALVE REPLACEMENT AND BIOPROSTHETIC HEART VALVES. SOME CAUSES FOR THROMBOEMBOLISM NOT ASSOCIATED WITH INVASIVE PROCEDURES INCLUDE ADVANCED AGE, ATHEROSCLEROSIS, CANCER, PREVIOUS MI, HEART FAILURE, DM, HTN, A SEDENTARY LIFESTYLE, CERTAIN MEDICATIONS, AND SMOKING. IT IS THE NATURAL TENDENCY OF THE BODY TO FORM A CLOT ON FOREIGN OBJECTS IN THE VASCULAR SPACE. THESE PATIENTS ARE ANTICOAGULATED FOR THE PROCEDURE AND INTERVENTIONAL BEST PRACTICES MANDATE METICULOUS WIPING AND FLUSHING OF THE DEVICES TO PREVENT AND/OR REMOVE THE CLOT. THE THV TRAINING MANUALS AND IFU INSTRUCT THE OPERATOR TO ADMINISTER HEPARIN AND MAINTAIN THE ACT AT 250 SEC. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. THE EXACT CAUSE OF THE REPORTED EVENT WAS UNABLE TO BE DETERMINED BUT FACTORS SUCH AS INCREASED SIZE OF OUTER SHEATH DIAMETER, AS WELL AS GREATER NECROTIC CORE VOLUME IN THE COMMON FEMORAL ARTERY MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. 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.

    Description of Event or Problem · 0

    THROUGH REVIEW OF MEDICAL ARTICLE "COMPUTED TOMOGRAPHY DEFINED FEMORAL ARTERY PLAQUE COMPOSITION PREDICTS VASCULAR COMPLICATIONS DURING TRANSCATHETER AORTIC VALVE IMPLANTATION," THE FOLLOWING EVENT WAS IDENTIFIED AS PERTAINING TO AN EDWARDS DEVICE: ONE PATIENT WITH A 23MM SAPIEN 3 VALVE IMPLANTED IN AORTIC POSITION BY TRANSFEMORAL APPROACH HAD A MINOR VASCULAR COMPLICATION DUE TO AN ARTERIAL THROMBUS MANAGED CONSERVATIVELY, LATER READMITTED WITH ISCHEMIC LIMB REQUIRING VASCULAR SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1715902 EDWARDS ESHEATH INTRODUCER SET INTRODUCER, CATHETER DYB EDWARDS LIFESCIENCES 9610ES14 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention