BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ION¿

    MDR report key: 2213489 · Received August 16, 2011

    Report

    Report Number
    2134265-2011-03318
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 21, 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: 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

    SAME CASE AS MFR REPORT #: 2134265-2011-03319. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE PROCEDURE TREATED THE HEAVILY CALCIFIED UNSPECIFIED TARGET VESSEL. AN ION STENT WAS ADVANCED TO TREAT THE TARGET LESION BUT COULD NOT CROSS THE LESION AND THE STENT BUCKLED IN THE MIDDLE. A TAXUS ATOM STENT WAS ADVANCED BUT ALSO COULD NOT CROSS THE LESION AND BUCKLED AT THE TIP. THE LESION WAS DILATED WITH A SMALLER BALLOON AND THEN WITH A LARGER BALLOON AND THE FINALLY A DIFFERENT STENT WAS USED TO SUCCESSFULLY CROSS THE LESION. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS AN 85% STENOSED, 28MM IN LENGTH LESION LOCATED IN THE HEAVILY CALCIFIED DIAGONAL BRANCH. THERE WAS NO VESSEL TORTUOUSITY. THE STENT WAS DISPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ION¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902424220 14168073

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR