BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2884711 · Received December 24, 2012

    Report

    Report Number
    2015691-2012-18951
    Event Type
    Injury
    Date Received
    December 24, 2012
    Date of Event
    December 7, 2012
    Report Date
    December 7, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE SAPIEN VALVE INSTRUCTIONS FOR USE (IFU) AND THE THV TRAINING GUIDE, PARAVALVULAR LEAK, VALVE MALPOSITION, AND AORTIC INSUFFICIENCY ARE KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE TRANSAORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. PARAVALVULAR LEAK CAN OCCUR AS A RESULT OF A LACK OF APPROPRIATE SEALING OF THE VALVE TO THE TARGET SITE WHICH CAN OCCUR DUE TO UNEVEN DISTRIBUTION OF CALCIUM. PHYSICIANS ARE EXTENSIVELY TRAINED BE EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE SAPIEN THV. TRAINING INCLUDES DEVICE PREPARATION, APPROACH, DEPLOYMENT, IMAGING, PROCEDURE-SPECIFIC TRAINING MANUALS AND PROCTORED PROCEDURES. THE CORRECT ALIGNMENT AND POSITIONING OF THE DEVICE AT THE POINT OF DEPLOYMENT IS EMPHASIZED AS A KEY FACTOR TO THE PLACEMENT AND FIXATION OF THE DEVICE. IN THIS CASE, PATIENT AND PROCEDURAL FACTORS APPEAR TO HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. SINCE THERE IS NO ALLEGATION OF DEVICE MALFUNCTION, OR LABELING ISSUES, AND THE DEVICE WAS NOT RETURNED FOR PHYSICAL EVALUATION, NO FURTHER INVESTIGATIONAL ACTIVITIES WILL BE PERFORMED. THE IFU AND EDWARDS THV PATIENT SCREENING 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 PREVENTIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM THE EDWARD'S CLINICAL SPECIALIST INDICATING THAT DURING A TRANSAPICAL TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE (TAVR) THE 23MM SAPIEN VALVE WAS DEPLOYED IN AN 80:20 (VENTRICULAR) POSITION WHICH LED TO MODERATE PARAVALVULAR LEAK. A SECOND VALVE WAS IMPLANTED SUPERIOR TO THE FIRST WITH OPTIMAL RESULTS; NO PARAVALVULAR LEAK OR CENTRAL AORTIC INSUFFICIENCY. FOLLOWING THE PROCEDURE THE PATIENT WAS IN STABLE CONDITION. PER REPORT, THE NATIVE VALVE AND LEAFLET CALCIFICATION WAS DESCRIBED AS MODERATE. PRE-DEPLOYMENT THE VALVE WAS POSITIONED 50:50 WITHIN THE ANNULUS. THE COAXIAL ALIGNMENT OF THE DELIVERY SYSTEM AND THE VALVE WAS GOOD. IMAGE INTENSIFIER ANGLE WAS ADEQUATE. VENTILATION WAS HELD DURING DEPLOYMENT AND THERE WAS NO LOSS OF PACING CAPTURE DURING VALVE DEPLOYMENT. PER REPORT IT IS LIKELY THIS EVENT WAS DUE TO THE VALVE BEING POSITIONED TO LOW IN THE ANNULUS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention