BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION¿

    MDR report key: 3012667 · Received March 20, 2013

    Report

    Report Number
    2134265-2013-01617
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 19, 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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #: 2134265-2013-01616. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. IN (B)(6) 2011, AFTER PRE-DILATION TWO OVERLAPPING ION STENTS [2.5X28MM, 2.5X12MM] WERE IMPLANTED IN THE 90% STENOSED TARGET LESION LOCATED IN THE MODERATELY CALCIFIED AND MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY. POST DILATION WAS PERFORMED AND BOTH STENTS WERE WELL EXPANDED AND WELL APPOSED. IN (B)(6) 2013 THE PATIENT RETURNED AND HAD AN ANGIOGRAM REVEALING THAT THE TWO OVERLAPPED ION STENTS HAD DEFORMED AND NARROWED. NEXT, TREATMENT DILATED THE AREA AND PLACED ANOTHER UNSPECIFIED STENT IN THE MIDDLE SECTION WHERE THE ION STENTS HAD NARROWED. POST DILATION WAS THEN PERFORMED AND THEN ANOTHER UNSPECIFIED PROMUS ELEMENT PLUS STENT WAS PLACED TO COMPLETE THE PROCEDURE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116289 ION¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902428250

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 2.5X12MM ION STENT