BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS COMMANDER DELIVERY SYSTEM

    MDR report key: 5134603 · Received October 8, 2015

    Report

    Report Number
    2015691-2015-02650
    Event Type
    Injury
    Date Received
    October 8, 2015
    Date of Event
    September 15, 2015
    Report Date
    September 15, 2015
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE INSTRUCTIONS FOR USE, 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 AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THERE ARE SEVERAL POTENTIAL ETIOLOGIES FOR VENTRICULAR PERFORATION DURING A TAVR 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, PROCEDURAL FACTORS (GUIDEWIRE MANIPULATION) LIKELY CONTRIBUTED TO THE VENTRICULAR PERFORATION. 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.

    Description of Event or Problem · 1

    DURING A TRANSFEMORAL TAVR PROCEDURE, A 26MM SAPIEN 3 VALVE WAS SUCCESSFULLY DEPLOYED WITH A FINAL POSITION OF 80:20 AORTIC/VENTRICULAR (A/V). A POST DEPLOYMENT ROOT INJECTION REVEALED AORTIC INSUFFICIENCY (AI). THE PATIENT THEN EXPERIENCED A DROP IN BLOOD PRESSURE (BP) AND A PERICARDIAL EFFUSION WAS OBSERVED. PERICARDIOCENTESIS WAS PERFORMED FOLLOWED BY A PERICARDIAL WINDOW. NO ADDITIONAL PATCH OR SURGICAL REPAIR WAS REQUIRED. ONCE THE TAMPONADE WAS RELIEVED THE BP RETURNED TO BASELINE. THE PATIENT WAS FURTHER TREATED WITH A TRANSFUSION OF 2 UNITS OF BLOOD. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS TRANSFERRED IN STABLE CONDITION. THE NATIVE ANNULUS MEASURED 21.7MM X 26.9MM BY CT WITH A VALVE AREA OF 466MM2. SEVERE ANNULAR CALCIFICATION, MODERATE-SEVERE NATIVE LEAFLET CALCIFICATION AND MODERATE AORTIC ROOT CALCIFICATION WERE REPORTED. IT WAS PERCEIVED THAT THE PRE-SHAPED GUIDEWIRE LIKELY CONTRIBUTED TO THE VENTRICULAR PERFORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666483 EDWARDS COMMANDER DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9600LDS26 60112261

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention