BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3023117 · Received March 27, 2013

    Report

    Report Number
    2015691-2013-19668
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 5, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. PER THE INSTRUCTIONS FOR USE (IFU), REGURGITATION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THERE ARE SEVERAL PATIENT AND PROCEDURAL FACTORS THAT ALONE OR IN COMBINATION CAN CAUSE OR CONTRIBUTE TO REGURGITATION, INCLUDING IMPROPER SIZING OF THE NATIVE VALVE, MALPOSITIONING OF THE PROSTHESIS (TOO AORTIC OR TOO VENTRICULAR), AND SEVERE NATIVE ANNULAR CALCIFICATION. THE PROCEDURAL DIDACTIC INSTRUCTS THE OPERATOR ON PROPER POSITIONING AND DEPLOYMENT OF THE VALVE, INCLUDING ALL PROCEDURAL AND ANATOMICAL CONSIDERATIONS. IN THIS CASE, THE CAUSE OF THE EVENT APPEARS TO BE RELATED TO THE PINNING OF A LEAFLET BY 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 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 AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED PER THE EDWARDS FIELD CLINICAL SPECIALIST (FCS), DURING A TRANSFEMORAL TAVR PROCEDURE, THE FIRST VALVE DEPLOYED IN GOOD 60:40 AORTIC WITH MODERATE TO SEVERE CENTRAL AORTIC INSUFFICIENCY (CAI) WAS NOTED ON FLUORO AFTER DEPLOYMENT. THE WIRE WAS MANIPULATED TO CENTRALIZE, HOWEVER CAI REMAINED. A SECOND VALVE WAS PLACED HIGHER WITHIN THE FIRST, BUT THE CAI DID NOT RESOLVE. THE PATIENT REQUIRED CHEST COMPRESSIONS. A SOFT CATHETER WAS PLACED ACROSS THE VALVE. THE CAI IMPROVED TO MILD. THE PATIENT SLOWLY STARTED TO RECOVER AND AN IABP WAS PLACED FOR SUPPORT. ADDITIONAL INVESTIGATION REVEALED THE FOLLOWING: THE NATIVE VALVE/LEAFLET CALCIFICATION WAS MODERATE. THE COAXIAL ALIGNMENT OF THE DELIVERY SYSTEM AND VALVE WAS CONSIDERED GOOD, AS WAS THE IMAGE INTENSIFIER ANGLE. THE PATIENT'S NATIVE ANNULUS DIAMETER WAS 21MM, MEASURED BY TTE. PER REPORT, THE PHYSICIANS ATTRIBUTED THE CAI TO THE WIRE PINNING A LEAFLET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125762 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23 3050851

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention