BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE

    MDR report key: 4862020 · Received June 23, 2015

    Report

    Report Number
    2015691-2015-01486
    Event Type
    Injury
    Date Received
    June 23, 2015
    Date of Event
    February 24, 2015
    Report Date
    June 2, 2015
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    REVIEW OF FLUORO IMAGES PERFORMED BY EDWARDS PHYSICIAN PROCTOR: MODERATE-SEVERE CALCIFICATION OF LEAFLETS (NC, RC AND LC), MODERATE MILD TO MODERATE CALCIUM AT THE LEVEL OF STJ, LM AND ASCENDING AORTA. DURING BAV AND THE 2 IMPLANTS, THE WIRE TIP DOESN¿T REACH THE APEX BUT IS IN A SHALLOW POSITION IN THE MIDDLE OF THE VENTRICLE WITHOUT ENOUGH SUPPORT. FIRST IMPLANT ENDED 100% ABOVE THE ANNULUS. THE ACTUAL IMPLANT SHOT IS NOT SEEN BUT PACEMAKER LOSS OF CAPTURE WAS DESCRIBED IN THE REPORT AND MAY BE THE CAUSE OF THE AORTIC DEPLOYMENT. SECOND IMPLANT LANDED 60% BELOW THE ANNULUS (AND FIRST VALVE) WITH MILD AI (DETERMINED BY FLUORO; THERE ARE NO INTRA-OP TEE IMAGES) UNCLEAR WHY INTRA-OPERATIVE TEE IMAGES WERE NOT PROVIDED, AS THE TEE PROBE IS VISIBLE IN THE FLUORO IMAGES DURING THE IMPLANT (B)(6) 2014. TTE 1 DAY POST OP (B)(6) 2014 AND (B)(6) 2014 (APPROXIMATELY 2 MONTHS LATER) TEE IMAGES ARE AVAILABLE. THE 2 ECHOES (1 POST OP AND 2 MONTHS LATER) ARE NOT REALLY DIFFERENT; MILD TO MODERATE CENTRAL AI IS SEEN IN BOTH. IT¿S ALMOST IMPOSSIBLE TO SEE THE LEAFLETS.

    Description of Event or Problem · 1

    THREE MONTHS POST VALVE-IN-VALVE PROCEDURE (26MM SAPIEN XT X 2), THE PATIENT DEVELOPED CENTRAL AORTIC INSUFFICIENCY (CAI) AND PRESENTED IN CONGESTIVE HEART FAILURE. IT WAS REPORTED THAT THERE WAS "A FAILURE OF THE LEAFLETS¿. IT WAS DECIDED TO DEPLOY A 29MM CORE-VALVE INSIDE THE 26MM EDWARDS SAPIEN VALVE. THE PATIENT WAS STABLE POST PROCEDURE. DURING THE INITIAL PROCEDURE (3 MONTHS PRIOR), THE FIRST VALVE LANDED 90:10 AORTIC/VENTRICULAR (A/V) DUE TO LOSS OF PACING CAPTURE. A SECOND VALVE WAS PLACED WITHIN THE FIRST VALVE, 40:60 A/V TO THE NATIVE ANNULUS, LEAVING THE PATIENT WITH TRACE REGURGITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406877 EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9300TFX26A

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention