BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 3013332 · Received March 20, 2013

    Report

    Report Number
    2134265-2013-01560
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 19, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION TREATMENT PROCEDURE STENT DAMAGE OCCURRED. SLOW FLOW WAS NOTED IN THE SAPHENOUS VEIN GRAFT. A 2.75X16MM VERIFLEX STENT WAS ADVANCED THROUGH A SAPHENOUS VEIN GRAFT (SVG) TO TREAT THE OBTUSE MARGINAL BRANCH. THE STENT DELIVERY SYSTEM WAS REMOVED DUE TO THE SLOW FLOW/NO FLOW IN THE SAPHENOUS VEIN GRAFT. ANOTHER 3X28MM VERIFLEX STENT WAS ADVANCED AND REMOVED AS THERE STILL SHOWED SLOW FLOW/NO FLOW. THEY DECIDED TO DO ASPIRATION AT THE ANEURYSMAL DISTAL PORTION OF THE SAPHENOUS VEIN GRAFT THAT ALREADY HAD A 4X38MM ION STENT THAT WAS PLACED IN 2011. A RUNWAY GUIDE CATHETER WAS INSERTED AND WAS AT THE PROXIMAL PORTION OF THE STENT. THE ASPIRATION CATHETER WOULD NOT ADVANCE AFTER MULTIPLE ATTEMPTS. WHILE ATTEMPTING TO ADVANCE THE ASPIRATION CATHETER IT WAS CAUGHT UP ON THE PREVIOUS PLACED ION STENT AND RAISED A FEW STENT STRUTS. WENT IN WITH A 4X12MM APEX BALLOON CATHETER AND WAS ABLE TO SUCCESSFULLY ADVANCE THE ASPIRATION CATHETER ACROSS THE PROXIMAL PORTION OF THE VESSEL. ONCE THE BALLOONING WAS COMPLETED, THE ASPIRATION CATHETER WAS USED TO COMPLETE THE CASE SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115140 ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE UNK692

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention (2) 2.75X16 VERIFLEX STENT| RUNWAY GUIDE CATHETER