BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 2221182 · Received August 24, 2011

    Report

    Report Number
    2134265-2011-03547
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    July 27, 2011
    Report Date
    July 27, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. 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 STENTING TREATMENT PROCEDURE, STENT DISLODGEMENT OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED, IN-STENT RESTENOSED MID RIGHT CORONARY ARTERY (RCA). A 3.50X16MM ION STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE UNKNOWN PREVIOUSLY PLACED RESTENOSED STENT. THE PHYSICIAN PLACED THE ION STENT INSIDE OF THE RESTENOSED STENT AND THEN PULLED NEGATIVE ON THE BALLOON. WHEN THE PHYSICIAN WENT TO TAKE ONE MORE PICTURE BEFORE DEPLOYMENT, THE PATIENT STARTED TO HAVE A SEVERE VESSEL SPASM AND WHEN THE PHYSICIAN PULLED BACK ON THE SDS, THE STENT BECAME DISLODGED; HOWEVER, IT DID REMAIN ON THE WIRE IN THE VESSEL. A 2.0X15MM APEX BALLOON WAS INSERTED INTO THE DISLODGED STENT AND WAS INFLATED TO 14ATMS. THE STENT DELIVERY BALLOON WAS THEN ADVANCED INTO THE STENT AND INFLATED TO 16ATMS. A 4.0X15MM QUANTUM APEX BALLOON WAS USED TO POST DILATE THE STENT. IT WAS NOTED THAT THE ION STENT REMAINED IN THE INTENDED LOCATION IN THE VESSEL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT COMPLICATIONS REPORTED. THE PATIENT'S CURRENT CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902416350 14327641

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention RUNWAY GUIDE CATHETER| WHISPER GUIDE WIRE