BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2922467 · Received January 18, 2013

    Report

    Report Number
    2015691-2013-19138
    Event Type
    Injury
    Date Received
    January 18, 2013
    Date of Event
    December 26, 2012
    Report Date
    December 26, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    P100041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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, PARAVALVULAR LEAK IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH BIOPROSTHETIC HEART VALVE AND THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THE EDWARDS SAPIEN RETROFLEX 3 TRANSFEMORAL DELIVERY SYSTEM TRAINING GUIDE INSTRUCTS THE OPERATOR ON PROPER POSITIONING AND DEPLOYMENT OF THE VALVE, INCLUDING ALL PROCEDURAL AND ANATOMICAL CONSIDERATIONS. IN ADDITION, THE PATIENT SCREENING MANUAL AND THE PROCEDURE DIDACTIC IDENTIFY SEVERAL PROCEDURAL AND ANATOMICAL FACTORS WHICH COULD CONTRIBUTE TO PARAVALVULAR LEAK, INCLUDING DEVICE MALPOSITIONING, INACCURATE MEASUREMENT OF THE NATIVE VALVE ANNULUS, IMPROPER VALVE SIZING, AND UNEVEN DISTRIBUTION OF CALCIUM ON THE NATIVE VALVE. IN THIS CASE, IT APPEARS THAT THE REPORTED MODERATE PVL WAS RELATED TO THE POSITION OF THE SAPIEN VALVE IN RELATION TO THE CALCIUM BURDEN OF THE NATIVE AORTIC VALVE. 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 AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, FOLLOWING DEPLOYMENT OF A 26MM SAPIEN VALVE MODERATE PARAVALVULAR LEAK (PVL) WAS NOTED ON TEE. POST DILATION WITH A 26MM X 4CM ZMED BALLOON WITH 24CC OF CONTRAST DID NOT RESOLVE THE PVL. THE PHYSICIAN FELT THAT IMPLANTING A SECOND 26MM SAPIEN VALVE SLIGHTLY MORE VENTRICULAR MAY REDUCE OR TOTALLY RESOLVE THE PVL. BECAUSE THE PATIENT WAS YOUNGER THAN AVERAGE AGE ((B)(6)), THE PHYSICIAN FELT IT WAS NECESSARY TO ATTEMPT TO RESOLVE AS MUCH PVL AS POSSIBLE. A SECOND 26MM SAPIEN WAS PREPPED AND IMPLANTED SLIGHTLY LOWER THAN THE FIRST. POST DEPLOYMENT TEE SHOWED NO DISCERNIBLE PVL. ADDITIONAL INVESTIGATION REVEALED THE FOLLOWING: THE SAPIEN VALVE WAS IN A 50:50 POSITION AND DID NOT MOVE DURING DEPLOYMENT. THE MD FELT THE CAUSE OF THE PVL MAY HAVE BEEN THAT THE VALVE WAS NOT OPTIMALLY PLACED AND THERE WAS PVL AROUND IT DUE TO THE LOCATION OF THE VALVE IN RELATION TO THE CALCIUM BURDEN IN THE NATIVE ANNULUS. WHILE THE LEAK WAS MINIMAL, HE FELT THE PATIENT WOULD BE BEST SERVED IN TRYING TO REDUCE THE PVL AS MUCH AS POSSIBLE. HIS SOLUTION TO THIS WAS TO PLACE A SECOND VALVE WITHIN THE FIRST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27089 EDWARDS SAPIEN TRANSCATHETER HEART VALVE TRANSCATHETER HEART VALVE LWR EDWARDS LIFESCIENCES 9000TFX26A 12-AUG-2014

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention