BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS TRANSFEMORAL DELIVERY SYSTEM

    MDR report key: 7656549 · Received July 2, 2018

    Report

    Report Number
    2015691-2018-02579
    Event Type
    Injury
    Date Received
    July 2, 2018
    Date of Event
    April 1, 2015
    Report Date
    June 7, 2018
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: F10, H6. REFERENCE CAPA-20-00141.

    Additional Manufacturer Narrative · 0

    REF. RELATED MFGR. REPORT NUMBERS: 2015691-2018-02559, 2015691-2018-02560, 2015691-2018-02578, 2015691-2018-02579, 2015691-2018-02582, 2015691-2018-02584, 2015691-2018-02586.

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS TREATED BETWEEN (B)(6) 2015 AND (B)(6) 2017. THE TYPE OF DELIVERY SYSTEM IS UNKNOWN; HOWEVER, THESE ARE THE POSSIBLE PMA NUMBERS FOR THE SAPIEN XT (NOVAFLEX+ DELIVERY SYSTEM/P130009) AND SAPIEN 3 (COMMANDER DELIVERY SYSTEM/P140031) VALVES. THE DEPLOYMENT POSITION IS UNKNOWN; HOWEVER, THESE ARE THE POSSIBLE CODES NPU (MITRAL) AND NPT (AORTIC). THE DELIVERY SYSTEM WAS NOT RETURNED TO EDWARDS LIFESCIENCES AS IT WAS DISCARDED BY THE FACILITY. PER THE INSTRUCTIONS FOR USE (IFU), CARDIOVASCULAR INJURIES, INCLUDING PERFORATION OR DISSECTION OF VESSELS, VENTRICLE, MYOCARDIUM OR VALVULAR STRUCTURES, ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH STANDARD CARDIAC CATHETERIZATION, BALLOON VALVULOPLASTY AND THE TRANSCATHETER VALVE REPLACEMENT (TVR) PROCEDURE. THERE ARE SEVERAL POTENTIAL ETIOLOGIES FOR VENTRICULAR PERFORATION DURING A TVR 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 INDICATION A PRODUCT DEFICIENCY CONTRIBUTED TO THIS ADVERSE EVENT. THE CAUSE OF THE VENTRICULAR PERFORATION CANNOT BE CONFIRMED, IT IS POSSIBLE THE EVENT WAS RELATED TO PROCEDURAL FACTORS (GUIDEWIRE, MANIPULATION OF DEVICES) OR THE MECHANISMS DESCRIBED ABOVE. 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. BIBLIOGRAPHY: PRAZ, FABIEN, ET AL. "TRANSATRIAL IMPLANTATION OF A TRANSCATHETER HEART VALVE FOR SEVERE MITRAL ANNULAR CALCIFICATION." THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY (2018).

    Description of Event or Problem · 1

    AS REPORTED THROUGH A JOURNAL ARTICLE TITLED, "TRANSATRIAL IMPLANTATION OF A TRANSCATHETER HEART VALVE FOR SEVERE MITRAL ANNULAR CALCIFICATION" POST TVR PROCEDURE, WHILE IN THE HOSPITAL (EXACT DATE UNKNOWN), ONE PATIENT WAS FOUND TO HAVE SUSTAINED A ¿VENTRICULAR FREE WALL INJURY FROM A WIRE PERFORATION¿ REQUIRING RE-EXPLORATION FIXED WITH SUTURES AND WITHOUT BYPASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498374 EDWARDS TRANSFEMORAL DELIVERY SYSTEM PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED NPU EDWARDS LIFESCIENCES TF DELIVERY SYSTEM UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention