BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RETROFLEX 3 SAPIEN DELIVERY SYSTEM

    MDR report key: 3024154 · Received March 27, 2013

    Report

    Report Number
    2015691-2013-19674
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE, CARDIOVASCULAR INJURIES, INCLUDING PERFORATION OR DISSECTION OF VESSELS, VENTRICLE, MYOCARDIUM OR VALVULAR STRUCTURES, WHICH MAY REQUIRE INTERVENTION 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 AND FIXATION OF THE TVP TO PREVENT VENTRICLE PERFORATION. PER THE PROCEDURE DIDACTIC, PATIENTS WITH SMALL VENTRICLES ARE AT PARTICULARLY HIGH RISK FOR VENTRICULAR PERFORATION. IN THIS CASE, THE DEFINITIVE CAUSE OF THE PERFORATION COULD NOT BE DETERMINED; HOWEVER, AS REPORTED, IT MAY HAVE BEEN DUE TO THE GUIDEWIRE. 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

    AS REPORTED BY THE EDWARDS TERRITORY MANAGER, APPROXIMATELY 10 TO 15 MINUTES AFTER SUCCESSFUL TRANSFEMORAL DEPLOYMENT OF A SAPIEN VALVE, THE PATIENT'S SYSTOLIC BLOOD PRESSURE DROPPED. ECHO NOTED WHAT APPEARED TO BE FLUID AROUND THE HEART. A MINI PERICARDIAL WINDOW WAS CREATED AND BLOOD WAS DRAINED FROM THE PERICARDIUM. A SMALL TEAR AT THE APEX OF THE HEART WAS SUTURED. IT WAS REPORTED THAT THE PATIENT REMAINED STABLE AND TOLERATED THE PROCEDURE WELL. ADDITIONAL INFORMATION REVEALED THE FOLLOWING: THE PERICARDIAL EFFUSION WAS REPORTED TO BE DUE TO A SMALL TEAR IN THE VENTRICLE POSSIBLY DUE TO THE COOK EXTRA STIFF GUIDEWIRE; HOWEVER THE PHYSICIAN COULD NOT DETERMINE THE EXACT CAUSE OF THE TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125752 RETROFLEX 3 SAPIEN DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9120FS23

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Required Intervention