BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ION?

    MDR report key: 4220893 · Received November 3, 2014

    Report

    Report Number
    2134265-2014-06642
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 9, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MFR: THE COMPLAINT 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 STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). A 16MM X 3.00MM ION¿ STENT WAS ADVANCED BUT WAS UNABLE TO CROSS AN UNKNOWN STENT THAT PREVIOUSLY IMPLANTED FOUR YEARS AGO. THE DEVICE WAS REMOVED HOWEVER IT WAS NOTED THAT ONE OF THE STENT STRUTS NEAR THE TIP WAS FLARED. THE PROCEDURE WAS COMPLETED USING A 2.75MM X 16MM ION¿ STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701992 ION? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902416300 16159344

    Patients

    Seq Age Sex Outcome Treatment
    1