BEUDAMED
    FDA Adverse Event Death Summary report: N

    PT GRAPHIX¿

    MDR report key: 5935650 · Received September 8, 2016

    Report

    Report Number
    2134265-2016-08106
    Event Type
    Death
    Date Received
    September 8, 2016
    Date of Event
    August 12, 2016
    Report Date
    August 12, 2016
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (HEREDIA)
    Product Code
    DQX
    PMA / PMN Number
    K965023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2016-08101. SAME CASE AS MDR ID: 2134265-2016-08102. SAME CASE AS MDR ID: 2134265-2016-08103. SAME CASE AS MDR ID: 2134265-2016-08104. SAME CASE AS MDR ID: 2134265-2016-08105. IT WAS REPORTED A PLAQUE SHIFT OCCURRED AND THE PATIENT EXPIRED. THE PATIENT PRESENTED WITH CHEST PAIN AS A NON STEMI. THE TARGET LESION WAS LOCATED IN THE FIRST OBTUSE MARGINAL BRANCH (OMB). THE PHYSICIAN WANTED TO PERFORM AN INTRAVASCULAR ULTRASOUND (IVUS) ON THE FIRST OMB AND THE PROXIMAL CIRCUMFLEX. A 182CM CHOICE PT GUIDEWIRE WAS ADVANCED IN THE FIRST OMB; AN IVUS CATHETER WAS UNABLE TO ADVANCE THROUGH OMB. A NON-BSC BALLOON WAS ADVANCED THROUGH THE OMB AND INFLATED WITH RESIDUAL WASTE ON THE BALLOON. THE PHYSICIAN THEN ADVANCED A FLEXTOME CUTTING BALLOON THROUGH THE FIRST OMB BUT WAS UNABLE TO CROSS THE LESION SUCCESSFULLY. THE CUTTING BALLOON WAS REMOVED AND A 1.2MM X 12MM THREADER BALLOON WAS ADVANCED AND INFLATED SUCCESSFULLY. AS THE THREADER BALLOON WAS BEING REMOVED, THE GUIDE CATHETER LOST POSITION AND PULLED THE BALLOON AND WIRE OUT OF THE LEFT MAIN. THE GUIDE CATHETER WAS REINSERTED AND AN ANGIOGRAM NOTED THAT THE CIRCUMFLEX CLOSED. AFTER MULTIPLE GUIDEWIRES (CHOICE PT AND PT GRAPHIX) WERE USED IN AN ATTEMPT TO GAIN ACCESS TO THE CIRCUMFLEX (TRYING TO RE-ESTABLISH FLOW), ONE WAS ABLE TO BE ADVANCED TO THE DISTAL CIRCUMFLEX AND A NON-BSC BALLOON WAS USED IN THE PROXIMAL CIRCUMFLEX. THE PATIENT THEN BECAME HYPOTENSIVE AND NONRESPONSIVE. AN UNKNOWN STENT WAS PLACED IN THE PROXIMAL CIRCUMFLEX. THE PATIENT CODED AND RESUSCITATION WAS PERFORMED. AN ANGIOGRAM WAS OBTAINED. TIMI2 FLOW WAS VISUALIZED WITH HAZINESS DISTAL TO THE IMPLANTED STENT AND A PLAQUE SHIFT WAS NOTED IN THE DISTAL LEFT MAIN. THE STENT DELIVERY DEVICE WAS RE-ADVANCED TO THE DISTAL LEFT MAIN AND WAS INFLATED AS WELL AS DISTAL TO THE STENT. ANOTHER ANGIOGRAM WAS TAKEN. A VENTRICULAR ASSIST DEVICE (VAD) WAS PLACED AS CARDIOPULMONARY RESUSCITATION (CPR) WAS BEING PERFORMED BUT THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587551 PT GRAPHIX¿ WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) H74914914011 0018664635

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death