BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS COMMANDER DELIVERY SYSTEM WITH S3U

    MDR report key: 10925179 · Received December 1, 2020

    Report

    Report Number
    2015691-2020-14769
    Event Type
    Death
    Date Received
    December 1, 2020
    Date of Event
    November 5, 2020
    Report Date
    November 5, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE REFERENCE RELATED MANUFACTURER REPORT NO: 2015691-2020-14771.

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    AS REPORTED, POST TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE WITH A 23MM SAPIEN 3 ULTRA VALVE, CT SHOWED A DESCENDING AORTIC DISSECTION/RUPTURE.  THE TAVR PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS.  THE PATIENT HAD A PACEMAKER IMPLANTED DUE TO HEART BLOCK THE SAME NIGHT OF THE PROCEDURE.  THE PATIENT¿S STATUS DECLINED LATE THAT EVENING AND THE PATIENT EXPIRED ON POSTOPERATIVE DAY 1.  THERE WAS NO PERCEPTION FROM THE OPERATORS THAT A DEVICE MALFUNCTION OCCURRED.  IT WAS POSSIBLE THAT THE PUSH CATHETER CAUGHT ON TRANSVERSE ARCH PLAQUE WHEN RE-ADVANCING TO POST DILATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1395077 EDWARDS COMMANDER DELIVERY SYSTEM WITH S3U AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9750CM23A

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Death