BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 2213113 · Received August 16, 2011

    Report

    Report Number
    2134265-2011-03403
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 20, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RECEIVED 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, REMOVAL DIFFICULTIES AND PARTIAL DEPLOYMENT OCCURRED. THE TARGET LESION WAS LOCATED AT THE DISTAL RIGHT CORONARY ARTERY (RCA). AFTER PLACING MULTIPLE STENTS, A 24X2.25MM ION STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT IT DID NOT CROSS THE DISTAL LESION. IT WAS NOTED THAT THE DEVICE HAD TO BE ADVANCED THROUGH MULTIPLE STENTS. UPON REMOVAL, THE SDS GOT STUCK AND THE STENT WAS DEPLOYED. UPON DEPLOYMENT, ONLY THE PROXIMAL HALF OF THE STENT EXPANDED. THE DELIVERY SYSTEM WAS REMOVED AND A DIFFERENT BALLOON CATHETER WAS ADVANCED TO FULLY DEPLOY THE DISTAL END OF THE STENT. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    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 H7493902424220

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention