BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

    MDR report key: 6006324 · Received October 6, 2016

    Report

    Report Number
    2015691-2016-02964
    Event Type
    Injury
    Date Received
    October 6, 2016
    Date of Event
    September 14, 2016
    Report Date
    September 14, 2016
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIRST VALVE PROCEDURAL CINE, FOLLOW UP ECHOES, VALVE IN VALVE PROCEDURAL CINE, VALVE IN VALVE POST-IMPLANT ECHO WERE PROVIDED TO EDWARDS AND REVIEWED BY AN EDWARDS PHYSICIAN PROCTOR. THE FINDINGS ARE SUMMARIZED BELOW: 1ST VALVE PROCEDURAL CINE: 3 SOV SEEN, BICUSPID VALVE POSSIBLY TYPE 1. BAV X3. FIRST TWO BAV NOT EFFECTIVE AS BALLOON MOVES, 3RD BAV EFFECTIVE. VALVE IMPLANT DONE WELL. VALVE COAXIAL, SLOW INFLATION, LOSS OF CAPTURE SEEN WITH GOOD RECOVERY. VALVE FULLY EXPANDED. VALVE APPEARS LOW IN ANNULUS (APPROX. 70:30). POST INJECTION SHOWS CENTRAL AI WITH WIRE AGAINST VALVE LEAFLET, NO CLEAR IMAGES OF PVL SEEN; (CONTRAST DILUTED). POST DILATATION WITH DS. FINAL IMAGE SHOWS NO CLEAR IMAGE OF CAI OR PVL (CONTRAST DILUTED) F/U ECHO POD12 (TEE): 1 SINGLE JET PVL SEEN IN LCC. APPEARS MILD-MOD COMPARED TO CINE ( CONTRAST DILUTED NO CLEAR IMAGE). PVL APPEARS 15% OF CIRCUMFERENTIAL AREA VIV PROCEDURAL CINE POD14. FIRST IMAGE (NO CONTRAST INJECTION) SHOWS VALVE IN SAME POSITION AND STENT EXPANDED AS IT WAS ON THE LAST IMAGE OF THE IMPLANT. CONTRAST INJECTION (APPEARS NOT DILUTED) SHOWS MODERATE PVL LCC AND CALCIUM AT SITE. VIV DEPLOYED 25% LOWER THAN THE FIRST ONE. PVL STILL SEEN IN LCC VIV POST-IMPLANT ECHO POD14 (TTE): PVL APPEARS DECREASED TO MILD IMPRESSIONS: THREE SINUS OF VALSALVA SEEN, BICUSPID PATIENT POSSIBLE TYPE 1. BAV X3, LAST BAV EFFECTIVE. THE VALVE WAS FULLY EXPANDED BUT APPEARS MORE VENTRICULAR THAN RECOMMENDED IN A BICUSPID VALVE. CENTRAL AORTIC INSUFFICIENCY (CAI) SEEN BUT MAY BE DUE TO WIRE AGAINST LEAFLET. CONTRAST INJECTIONS POST IMPLANT APPEARS DILUTED AND DOES NOT SHOW ANY CLEAR PVL OR CAI. POST DILATATION WAS SEEN. NO ECHO PROVIDED OF INITIAL IMPLANT OR POST IMPLANT. POD12 ECHO SHOWS MILD-MOD PVL. VALVE IN VALVE CINE SHOWS INITIAL VALVE IN THE SAME POSITION AND FULLY EXPANDED AS IT WAS AT THE END OF THE FIRST PROCEDURE. THE VALVE DOES NOT APPEAR TO HAVE MIGRATED OR RECOILED AS REPORTED. CONTRAST INJECTION NOW SHOWS MODERATE PVL IN LCC (CONTRAST LOOKS UNDILUTED) AND CALCIUM AT SITE. THE VALVE IN VALVE WAS DEPLOYED 25% LOWER IN THE VENTRICLE BUT DOES NOT APPEAR TO COVER THE PVL AREA. ECHO POST VALVE IN VALVE SHOWS PVL DECREASED TO MILD. RECOMMENDATIONS: IF PVL IS RELATED TO CALCIUM AND DOES NOT IMPROVE WITH POST DILATATION, CONSIDER USING A VASCULAR OR NON-COMPLAINT BALLOON 30MM IN ORDER TO STRETCH THE STENT. PER THE INSTRUCTIONS FOR USE, PARAVALVULAR LEAK (PVL) IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH BIOPROSTHETIC HEART VALVES. PARAVALVULAR LEAK REFERS TO BLOOD FLOWING THROUGH A CHANNEL BETWEEN THE STRUCTURE OF THE IMPLANTED VALVE AND THE CARDIAC TISSUE, AS A RESULT OF A LACK OF APPROPRIATE SEALING OF THE VALVE TO THE TARGET SITE. SOME PVL IS NOT UNCOMMON POST DEPLOYMENT. MANY CASES ARE MILD TO MODERATE, AND EITHER RESOLVE OVER TIME OR DO NOT CAUSE SYMPTOMS. OTHERS MAY BE MORE CLINICALLY SIGNIFICANT AND REQUIRE INTERVENTION. THE MECHANISM BEHIND WORSENING OR LATE PVL IS NOT WELL UNDERSTOOD BUT MAY BE RELATED TO CARDIAC REMODELING. IN THIS CASE, ALTHOUGH THE EXACT CAUSE OF THE WORSENING PVL TWO WEEKS POST TAVR CANNOT BE CONFIRMED, IT IS POSSIBLE THAT THE PATIENT¿S BICUSPID VALVE AND/OR INITIAL VALVE POSITION (30:70 AORTIC/VENTRICULAR) MIGHT HAVE CONTRIBUTED TO THE WORSENING PVL. 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.

    Additional Manufacturer Narrative · 1

    CORRECTION/ADDITIONAL INFORMATION: EVALUATION CODES.

    Description of Event or Problem · 1

    AS REPORTED BY THE (B)(4) EDWARDS AFFILIATE, TWELVE DAYS POST DEPLOYMENT OF A 26MM SAPIEN 3 VALVE, THE PATIENT PRESENTED TO THE HOSPITAL WITH HEART FAILURE, CHEST INFECTION AND MODERATE TO SEVERE PARAVALVULAR LEAK (PVL) UP FROM TRIVIAL AT POST DEPLOYMENT. TWO DAYS AFTER READMISSION, A SECOND 26MM SAPIEN 3 VALVE WAS IMPLANTED. THE SECOND VALVE WAS POSITIONED APPROXIMATELY HALF A (LARGE UPPER) CELL LOWER THAN THE ORIGINAL VALVE WHICH HAD BEEN PLACED IN AN 80:20 AORTIC POSITION. POST DEPLOYMENT TTE SHOWED THE PVL REDUCED TO MILD AND THE PATIENT'S HEMODYNAMICS IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660454 EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9600TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention