BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS RETROFLEX 3/SAPIEN DELIVERY SYSTEM

    MDR report key: 3905116 · Received July 1, 2014

    Report

    Report Number
    2015691-2014-01491
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 18, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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, 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, IN ADDITION TO PROCEDURAL FACTORS (MANIPULATION OF THE DELIVERY SYSTEM), PATIENT FACTORS INCREASING THE RISK OF VENTRICLE INJURY (FEMALE GENDER, ADVANCED AGE, CHRONIC STEROID USE, LARGE ATHEROMA IN THE AORTIC ARCH) WERE PRESENT AND MAY HAVE CONTRIBUTED TO THIS EVENT. 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 THE TRANSFEMORAL TAVR, A VENTRICLE PERFORATION BY THE GUIDE WIRE OCCURRED DUE TO THE AMOUNT OF FORCE REQUIRED TO ADVANCE THE DELIVERY SYSTEM BEYOND ATHEROMA IN THE AORTIC ARCH. DIFFICULTIES WERE ENCOUNTERED WHILE CROSSING THE AORTIC ARCH, FIRST WITH THE BAV BALLOON THEN WITH THE RETROFLEX DELIVERY SYSTEM AND VALVE, DUE TO A LARGE ATHEROMA IN THE AORTIC ARCH. SEVERAL MANIPULATIONS OF THE DELIVERY SYSTEM WERE REQUIRED TO HELP FACILITATE CROSSING THE LESION. THE DELIVERY SYSTEM WAS NOTED TO HAVE ¿JUMPED¿ WHEN IT ADVANCED. THE PATIENT BECAME HYPOTENSIVE AND DEVELOPED CARDIAC TAMPONADE. PERICARDIOCENTESIS WAS PERFORMED AND A "SIGNIFICANT" AMOUNT OF BLOOD WAS REMOVED FROM THE PERICARDIAL SPACE. THE PATIENT WAS STABILIZED AND THE VALVE WAS SUCCESSFULLY DEPLOYED. THE PATIENT WAS TRANSFERRED TO THE OR FOR SURGICAL EXPLORATION AND REPAIR OF THE SUSPECTED INJURY. THE PATIENT WAS PLACED ON BYPASS AND HER CHEST WAS OPENED. A LINEAR TEAR OF THE VENTRICLE, CONSISTENT WITH A WIRE EXCURSION, WAS FOUND. THE TEAR WAS SURGICALLY REPAIRED. THE PATIENT WAS REMOVED FROM BYPASS AND THE PROCEDURE WAS COMPLETED. FOLLOWING THE PROCEDURE, THE PATIENT WAS TRANSFERRED TO SICU IN STABLE CONDITION. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING IN THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384642 EDWARDS RETROFLEX 3/SAPIEN DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9120FS23 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention