BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 2152032 · Received July 7, 2011

    Report

    Report Number
    2134265-2011-02650
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 8, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS COMBINATION PRODUCT. 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

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE PARTIAL STENT DEPLOYMENT AND STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SAPHENOUS VEIN GRAFT (SVG) TO THE FIRST DIAGONAL ARTERY. A 2.25X16MM ION STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION AND WHEN THE PHYSICIAN DEPLOYED THE STENT AT 8ATMS, IT DID NOT FULLY EXPAND AS THE VESSEL WAS SMALLER THAN 2.25MM. THE STENT DELIVERY BALLOON WAS DEFLATED; HOWEVER, THE PHYSICIAN FELT THAT IT DID NOT "RELEASE" THE STENT. WHEN THE SDS WAS REMOVED FROM THE DEPLOYED STENT, THE STENT BECAME "ACCORDIONED" IN THE LESION. A NEW HIGH PRESSURE BALLOON CATHETER WAS ADVANCED FOR POSTDILATION AND WAS INFLATED INSIDE THE STENT WITH A GOOD RESULT. IT WAS NOTED THAT THE STENT REMAINED WELL POSITIONED AND APPOSED IN THE LESION. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS REPORTED. THE PATIENT'S CURRENT CONDITION IS OKAY.

    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 H7493902416220

    Patients

    Seq Age Sex Outcome Treatment
    1