BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN 3 TRANSCATHETER HEATH VALVE

    MDR report key: 11646290 · Received April 9, 2021

    Report

    Report Number
    2015691-2021-02402
    Event Type
    Injury
    Date Received
    April 9, 2021
    Date of Event
    March 15, 2021
    Report Date
    April 10, 2021
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPU
    UDI-DI
    00690103194364
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE (IFU), VALVE MALPOSITION AND EMBOLIZATION ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THERE ARE MULTIPLE PATIENT AND PROCEDURAL FACTORS THAT ALONE OR IN COMBINATION CAN CAUSE OR CONTRIBUTE TO VALVE MALPOSITION/EMBOLIZATION, INCLUDING, BUT NOT LIMITED TO, IMPROPER POSITIONING PRIOR TO DEPLOYMENT, POOR IMAGE INTENSIFIER ANGLE, POOR COAXIAL ALIGNMENT OF THE VALVE/DELIVERY SYSTEM, LOSS OF PACING CAPTURE, RAPID DEPLOYMENT AND MOVEMENT OF THE DELIVERY SYSTEM BY THE OPERATOR. THE EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE IS INDICATED FOR PATIENTS WITH SEVERE SYMPTOMATIC CALCIFIED NATIVE AORTIC VALVE STENOSIS. DEPLOYMENT OF THE SAPIEN 3 VALVE IN A NATIVE MITRAL VALVE IS NOT INDICATED PER THE LABELING; THEREFORE THE LABELING (IFUS AND EW TRAINING MANUALS) DO NOT INSTRUCT THE OPERATOR HOW TO POSITION THE SAPIEN 3 VALVE IN THIS SCENARIO. IN THIS CASE, THE VALVE WAS PLACED TOO ATRIAL IN THE NATIVE MITRAL POSITION RESULTING IN PVL. A SECOND DEVICE WAS REQUIRED. THE ROOT CAUSE OF THIS EVENT REMAINS INDETERMINABLE BUT WAS LIKELY DUE TO PATIENT AND PROCEDURE RELATED FACTORS (DEPLOYMENT IN THE NATIVE MITRAL ANNULUS). 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.

    Description of Event or Problem · 1

    EDWARDS RECEIVED NOTIFICATION FROM A SALES REP THAT DURING TRANSCATHETER VALVE REPLACEMENT OF A STENOSED NATIVE MITRAL VALVE A 29MM SAPIEN 3 WAS DEPLOYED TOO ATRIAL LEAKING TO A SIGNIFICANT JET OF MR. AS REPORTED, A LAMPOON PROCEDURE WAS DONE TO LACERATE THE ANTERIOR LEAFLET OF HER MITRAL VALVE PRIOR TO VALVE REPLACEMENT, CREATING SEVERE MR. A 29 S3 WITH +3 CC'S OF VOLUME WAS DEPLOYED BUT APPEARED TO BE TOO ATRIAL IN DEPTH (A SIGNIFICANT JET OF MR WAS VISUALIZED ON TEE). A SECOND 29 S3 WITH +3 CC'S VOLUME WAS DEPLOYED INSIDE THE FIRST AND THE MR JET WAS RESOLVED. HOWEVER, DURING DEPLOYMENT A LARGE PERICARDIAL EFFUSION WAS VISUALIZED ON TEE AS WELL. THE TEAM ATTEMPTED TO TAP THE EFFUSION AND PULLED A SIGNIFICANT AMOUNT OF BLOOD BUT IT DID NOT RESOLVE THE EFFUSION. THE PHYSICIAN OPENED THE CHEST AND ATTEMPTED TO SAVE THE PATIENT BUT EVENTUALLY IT WAS DECIDED THAT NOTHING COULD BE DONE. THE CAUSE OF THE EVENT WAS LIKELY AN INJURY TO THE ATRIO-VENTRICULAR (AV) GROOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541711 EDWARDS SAPIEN 3 TRANSCATHETER HEATH VALVE PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED NPU EDWARDS LIFESCIENCES 9600TFX29A 7862776 00690103194364

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death| R