BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION¿

    MDR report key: 3110963 · Received May 14, 2013

    Report

    Report Number
    2134265-2013-03047
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 15, 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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MFR: 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE A STENT FRACTURE OCCURRED. THE 90% STENOSED TARGET LESION BEING TREATED WAS LOCATED IN THE NON-TORTUOUS OSTIAL CIRCUMFLEX. PREDILATION WAS NOT PERFORMED. A 3.50X8MM ION STENT DELIVERY SYSTEM WAS ADVANCED AND DEPLOYED IN THE CIRCUMFLEX, FOLLOWED BY 2 INFLATIONS. A STENT FRACTURE WAS THEN NOTED. AN UNSPECIFIED BALLOON CATHETER WAS THEN ADVANCED AND POST-DILATION PERFORMED, HOWEVER, THE RESULT APPEARED WORSE. A 4.00X9MM NON-BSC STENT WAS THEN ADVANCED AND DEPLOYED INSIDE OF THE ION STENT WITH GOOD RESULT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213033 ION¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902408350 15385868

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention