BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DQX WIRE, GUIDE, CATHETER

    MDR report key: 10447007 · Received August 25, 2020

    Report

    Report Number
    3002808486-2020-00822
    Event Type
    Injury
    Date Received
    August 25, 2020
    Report Date
    September 7, 2020
    Product Code
    DQX
    PMA / PMN Number
    K061670
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). THIS REPORT WAS MISTAKENLY SUBMITTED AND IS A DUPLICATE OF REPORT UNDER MANUFACTURER REPORT # 3002808486-2016-01323. THIS REPORT IS CANCELLED AND ALL FUTURE INFORMATION WILL BE HANDLED UNDER 3002808486-2016-01323. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF# (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    THIS REPORT IS RELATED TO MDR # 1820334-2016-01054 ORIGINALLY SENT ON 14SEP2016, AND WAS CREATED TO CAPTURE A SECOND EVENT INDICATED IN THE LITERATURE ATTACHED. MACKRAM F. ELEID, MD., ET AL: PERCUTANEOUS TRANSVENOUS TRANSSEPTAL TRANSCATHETER VALVE IMPLANTATION IN FAILED BIOPROSTHETIC MITRAL VALVES, RING ANNULOPLASTY, AND SEVERE MITRAL ANNULAR CALCIFICATION JACC: CARDIOVASCULAR INTERVENTIONS 2016; 9:11, 1161-1174 THE ABOVE REFERENCED JOURNAL ARTICLE ALLEGED THAT A PATIENT¿S SUCCESSFUL MITRAL VALVE REPLACEMENT PROCEDURE WAS COMPLICATED BY AN INCIDENTALLY NOTED LV APICAL PSEUDOANEURYSM DISCOVERED ON TRANSTHORACIC ECHOCARDIOGRAM THE NEXT DAY, LIKELY CAUSED BY THE LV LUNDERQUIST ANCHOR WIRE. THE PSEUDOANEURYSM WAS SUCCESSFULLY TREATED WITH PERCUTANEOUS CLOSURE USING A 14 MM AMPLATZER VASCULAR PLUG II DEVICE 1 DAY AFTER THE VALVE-IN-VALVE PROCEDURE. IN A PREVIOUS REPORT 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 (MEDWATCH 1820334-2016-01054) DURING VALVE DEPLOYMENT OF LV APICAL PERFORATION DUE TO IRE/CATHETER NOSE CONE INJURY. THE PATIENT'S OUTCOME WAS UNKNOWN AS IT WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911400 DQX WIRE, GUIDE, CATHETER DQX

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention