BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 2140456 · Received June 27, 2011

    Report

    Report Number
    2134265-2011-02548
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 9, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    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).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - RETURNED PRODUCT CONSISTED OF A ION STENT DELIVERY SYSTEM (SDS) WITH NO ORIGINAL PACKAGING OR OTHER DEVICES. THE BALLOON WAS TIGHTLY FOLDED AND THE STENT WAS LOCATED BETWEEN THE MARKERBANDS. FOUR STRUTS IN THE FOURTH PROXIMAL ROW, TWO STRUTS IN THE FIFTH PROXIMAL ROW, AND FIVE STRUTS IN THE EIGHTH AND NINTH PROXIMAL ROWS WERE BENT BACK DISTALLY. THERE IS NO OTHER DAMAGE TO THE DEVICE. 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 PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY, STENT DAMAGE OCCURRED. THE 90% STENOSED LESION BEING TREATED WAS LOCATED IN THE FIRST DIAGONAL (D1). THE LESION WAS PRE-DILATED WITH 2.75X15MM APEX BALLOON. THE 2.75X12MM ION MR STENT WAS ADVANCED AND WOULD NOT CROSS THE LESION. THE PHYSICIAN WITHDREW THE DEVICE AND A BURR WAS NOTED ON THE STENT. A 3.0X20MM ION CROSSED THE LESION AND WAS DEPLOYED IN THE FIRST DIAGONAL. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY, STENT DAMAGE OCCURRED. THE 90% STENOSED LESION BEING TREATED WAS LOCATED IN THE FIRST DIAGONAL (D1). THE LESION WAS PRE-DILATED WITH 2.75X15MM APEX BALLOON. THE 2.75X12MM ION MR STENT WAS ADVANCED AND WOULD NOT CROSS THE LESION. THE PHYSICIAN WITHDREW THE DEVICE AND A BURR WAS NOTED ON THE STENT. A 3.0X20MM ION CROSSED THE LESION AND WAS DEPLOYED IN THE FIRST DIAGONAL. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS IS FINE.

    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 H7493902412270 13990132

    Patients

    Seq Age Sex Outcome Treatment
    1 BALLOON CATH: APEX 2.5X15MM