BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS ESHEATH INTRODUCER SET

    MDR report key: 20478296 · Received October 18, 2024

    Report

    Report Number
    2015691-2024-07931
    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

    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), CARDIOVASCULAR INJURY INCLUDING HEMATOMA, PERFORATION OR DISSECTION OF VESSELS, VENTRICLE, ATRIUM, SEPTUM, MYOCARDIUM OR VALVULAR STRUCTURES THAT MAY REQUIRE INTERVENTION ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED THE OVERALL TRANSCATHETER VALVE REPLACEMENT (TVR) PROCEDURE AND MAY REQUIRE INTERVENTION. A PSEUDOANEURYSM IS A LEAKAGE OF ARTERIAL BLOOD FROM AN ARTERY INTO THE SURROUNDING TISSUE WITH A PERSISTENT COMMUNICATION BETWEEN THE ORIGINATING ARTERY AND THE RESULTANT ADJACENT CAVITY. THIS MAY OCCUR AFTER ARTERIAL PUNCTURE FOR A DIAGNOSTIC CARDIAC CATHETERIZATION OR AN ARTERIOGRAM BUT IS MORE COMMON AFTER AN ARTERIAL INTERVENTION. CATHETER-DIRECTED INTERVENTIONS MORE COMMONLY REQUIRE LARGER ARTERIAL SHEATHS TO BE USED, AND THE ANTICOAGULATION OR ANTIPLATELET AGENTS THAT ARE ADMINISTERED CAN INTERFERE WITH NORMAL SEALING OF THE PUNCTURE SITE. SOME PSEUDOANEURYSMS RESOLVE THEMSELVES, THOUGH OTHERS REQUIRE TREATMENT TO PREVENT HEMORRHAGE, AN UNCONTROLLED LEAK, OR OTHER COMPLICATIONS. SURGERY IS SOMETIMES REQUIRED. EDWARDS EXTENSIVELY TRAINS PHYSICIANS BEFORE THEY ARE QUALIFIED TO USE THE TRANSCATHETER HEART VALVE (THV). TRAINING INCLUDES PATIENT SCREENING, DEVICE PREPARATION, APPROACH, DEPLOYMENT, IMAGING, PROCEDURE-SPECIFIC TRAINING MANUALS, AND PROCTORED PROCEDURES. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. THE CAUSE OF THE EVENT REMAINS UNKNOWN BUT FACTORS SUCH AS INCREASED SIZE OF OUTER SHEATH DIAMETER AND 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 26MM SAPIEN 3 VALVE IMPLANTED IN AORTIC POSITION BY TRANSFEMORAL APPROACH HAD A MAJOR VASCULAR COMPLICATION DUE TO A PSEUDOANEURYSM WITH UNPLANNED SURGICAL INTERVENTION RESULTING IN VARC TYPE 3 BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2271149 EDWARDS ESHEATH INTRODUCER SET INTRODUCER, CATHETER DYB EDWARDS LIFESCIENCES 9610ES14 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention