BEUDAMED
    FDA Adverse Event Death Summary report: N

    ADMIRAL XTREME

    MDR report key: 3982562 · Received August 6, 2014

    Report

    Report Number
    3004066202-2014-00123
    Event Type
    Death
    Date Received
    August 6, 2014
    Date of Event
    January 11, 2013
    Report Date
    July 29, 2014
    Manufacturer
    INVATEC SPA
    Product Code
    LIT
    PMA / PMN Number
    K062809
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CODES, RESULTS: PATIENT¿S CONDITION ¿ PREDISPOSED EVENT (INTERVENTION DUE TO WORSENING OF PATIENT CONDITION) EVALUATION CODES, CONCLUSIONS: OTHER (INTERVENTION DUE TO WORSENING OF PATIENT CONDITION) (B)(4).

    Description of Event or Problem · 1

    AN ADMIRAL XTREME STANDARD PTA BALLOON WAS USED TO TREAT AN OCCLUSION OF THE RIGHT BELOW THE KNEE VESSELS AND R-SFA. APPROXIMATELY 10 MONTHS POST THE PROCEDURE, THE PATIENT PRESENTED WITH WORSENING 'RIGHT LIMB PAD'. THIS EVENT WAS ASSESSED AS NOT RELATED TO THE DEVICE OR THE PROCEDURE. THE PATIENT WAS TREATED DURING A REVASCULARISATION OF THE RIGHT SFA WITH AN UNKNOWN STENT AND A BALLOON. THE EVENT WAS RESOLVED. APPROXIMATELY 20 MONTHS POST THE PROCEDURE, THE RIGHT SFA WAS TREATED WITH PTA DUE TO CRITICAL LEG ISCHEMIA. THIS EVENT WAS ASSESSED AS NOT RELATED TO THE DEVICE OR THE PROCEDURE. THE EVENT WAS RESOLVED. APPROXIMATELY 29 MONTHS LATER THE PATIENT WAS REPORTED TO HAVE EXPIRED DUE TO TERMINAL RENAL FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460620 ADMIRAL XTREME CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT INVATEC SPA

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Death