BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 2161465 · Received July 14, 2011

    Report

    Report Number
    2134265-2011-02656
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 14, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, 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 CORONARY ARTERY STENTING TREATMENT PROCEDURE A STENT DISLODGEMENT OCCURRED. THE LESION BEING TREATED WAS A 99% STENOSIS OF THE HEAVILY CALCIFIED RIGHT CORONARY ARTERY (RCA). THE LESION WAS APPROACHED VIA THE RIGHT RADIAL ARTERY. FOLLOWING DIAGNOSTIC VIEWS OF BOTH THE LEFT AND RIGHT CORONARY SYSTEMS, A 6F JR4 GUIDE CATHETER WAS ADVANCED AND A 0.014" NON-BSC GUIDE WIRE WAS ADVANCED ACROSS THE LESION. THE PHYSICIAN INTENDED TO DIRECT STENT THE RCA LESION USING A 3.5X12MM ION STENT; HOWEVER, THE STENT CAME OFF THE BALLOON IN THE RCA. THE PHYSICIAN ATTEMPTED TO SNARE THE ION STENT USING A 1.5X8MM APEX BALLOON, BUT WAS UNSUCCESSFUL. A NON-BSC SNARE WAS INTRODUCED AND RE-CAPTURED THE ION STENT. AT THAT POINT, THE RADIAL APPROACH WAS DISCONTINUED AND THE RIGHT FEMORAL WAS ACCESSED FOR FURTHER INTERVENTION. ADDITIONAL ATTEMPTS AT BALLOON ANGIOPLASTY USING A 2.5X12MM APEX AND 2.25X12MM NON-BSC BALLOON WERE UNSUCCESSFUL DUE TO INABILITY TO CROSS THE LESION. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR FURTHER INTERVENTION. THE PATIENT STATUS WAS 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 H7493902412350 14020654

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention