BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMMANDER DELIVERY SYSTEM

    MDR report key: 18508270 · Received January 12, 2024

    Report

    Report Number
    2015691-2024-00383
    Event Type
    Injury
    Date Received
    January 12, 2024
    Date of Event
    December 1, 2020
    Report Date
    January 12, 2024
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE REFERENCE RELATED MANUFACTURER REPORT NOS: 2015691-2024-00388, 2015691-2024-00385, AND 2015691-2024-00386.

    Additional Manufacturer Narrative · 0

    THE IMPLANTED VALVE MODEL AND SIZE IS UNKNOWN. POSSIBLE VALVE USED - EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE - PMA P140031 OR EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE - PMA P140031.THIS IS ONE OF FOUR MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE.CITATION: ARONEY, NICHOLAS P., ET AL. ''CLINICAL OUTCOMES FOLLOWING SINGLE ACCESS TRANSFEMORAL TRANSCATHETER AORTIC VALVE IMPLANTATION.'' CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 100.2 (2022): 227-232.PER THE INSTRUCTIONS FOR USE (IFU), CARDIOVASCULAR INJURIES SUCH AS PERFORATION OR DISSECTION OF VESSELS, VENTRICLE, MYOCARDIAL OR VALVULAR STRUCTURES ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE OVERALL THV PROCEDURE AND MAY REQUIRE INTERVENTION. THERE ARE SEVERAL POTENTIAL ETIOLOGIES FOR VENTRICULAR PERFORATION DURING A THV PROCEDURE, INCLUDING PERFORATION BY THE GUIDEWIRE, THE DELIVERY SYSTEM, OR THE TRANSVENOUS PACER (TVP) LEAD.PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE SAPIEN TRANSCATHETER HEART VALVE (THV). TRAINING INCLUDES PROPER GUIDEWIRE POSITIONING, FIXATION OF THE TVP TO PREVENT VENTRICLE PERFORATION, AND CAREFUL MANIPULATION OF DEVICES. PER THE PROCEDURE DIDACTIC, PATIENTS WITH SMALL VENTRICLES ARE AT PARTICULARLY HIGH RISK FOR VENTRICULAR PERFORATION.IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. WITH THE LIMITED INFORMATION PROVIDED, THE CAUSE OF THE VENTRICULAR PERFORATION IS UNKNOWN BUT MAY BE RELATED TO THE MECHANISMS ABOVE . 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 ASPART OF THIS MONTHLY REVIEW. AS SUCH, NEITHER A PRODUCT RISK ASSESSMENT, NOR CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME. NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    AS REPORTED BY THE EDWARDS EUROPEAN AFFILIATE, A REVIEW OF THE MEDICAL ARTICLE, ''CLINICAL OUTCOMES FOLLOWING SINGLE ACCESS TRANSFEMORAL TRANSCATHETER AORTIC VALVE IMPLANTATION'' WAS PERFORMED. THE FOLLOWING EVENT WAS IDENTIFIED AS PERTAINING TO AN EDWARDS DEVICE: ONE (1) PATIENT WITH AN UNKNOWN SAPIEN VALVE PRESENTED WITH LEFT VENTRICULAR WIRE PERFORATION AND TAMPONADE DURING THE PROCEDURE, WHICH REQUIRED PERICARDIOCENTESIS. THE OBJECTIVE OF THIS STUDY IS TO DETERMINE THE FEASIBILITY AND SAFETY OF SINGLE ACCESS TAVI, A NOVEL, AND MINIMALIST TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1817596 COMMANDER DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES COMMANDER DELIVERY SYSTEM UNKNOWN NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention