BEUDAMED
    FDA Adverse Event Death Summary report: N

    LUNDERQUIST EXCHANGE WIRE GUIDE

    MDR report key: 5949206 · Received September 14, 2016

    Report

    Report Number
    1820334-2016-01054
    Event Type
    Death
    Date Received
    September 14, 2016
    Report Date
    August 30, 2016
    Manufacturer
    COOK INC
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    "A TOTAL OF 33 PATIENTS UNDERWENT PERCUTANEOUS TRANSSEPTAL IMPLANTATION OF A VALVE WITHIN A DYSFUNCTIONAL MITRAL BIOPROSTHETIC VALVE (MODE OF FAILURE REGURGITATION IN 20, STENOSIS IN 11, COMBINED IN 2). OF THESE PROCEDURES, 31 (94%) WERE SUCCESSFUL, WHEREAS 2 (6%) DIED DURING VALVE DEPLOYMENT OF LV APICAL PERFORATION DUE TO IRE/CATHETER NOSE CONE INJURY." (B)(4); 2016 :1161-74)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602327 LUNDERQUIST EXCHANGE WIRE GUIDE DQX COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening