BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ION?

    MDR report key: 3202963 · Received July 2, 2013

    Report

    Report Number
    2134265-2013-04586
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    March 24, 2013
    Report Date
    June 4, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MFR.: THE COMPLAINT DEVICE WAS RECEIVED FOR ANALYSIS. THERE WAS CONTRAST IN THE INFLATION LUMEN. THE BALLOON WAS TIGHTLY FOLDED. THE STENT WAS SECURED ON THE BALLOON BETWEEN THE MARKERBANDS. THERE WERE THREE FLARED STRUTS IN THE FIRST DISTAL ROW OF STENT STRUTS. THERE WAS NO DAMAGE TO THE SDS. THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE STENT DAMAGE OR THE REPORTED CROSSING DIFFICULTY. 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

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(4) 2013. IT WAS REPORTED THAT DURING A CORONARY STENTING PROCEDURE CROSSING DIFFICULTIES WERE ENCOUNTERED. THE LESION WAS LOCATED IN THE HIGHLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 16MM X 2.25MM ION DRUG-ELUTING STENT WAS SELECTED TO TREAT BUT WAS UNABLE TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENTS STATUS POST PROCEDURE WAS STABLE. ANALYSIS OF THE RETURNED DEVICE REVEALED STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301917 ION? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902416220 15818722

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR