BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION?

    MDR report key: 2904158 · Received January 9, 2013

    Report

    Report Number
    2134265-2012-08456
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    March 28, 2012
    Report Date
    December 11, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    (B)(4). SAME PATIENT AS MDR #2134265-2012-07954. IT WAS REPORTED THAT DURING A STENTING TREATMENT, A DEPLOYMENT ISSUE OCCURRED. IN (B)(6) 2012, THE PATIENT EXPERIENCED SYNCOPAL EPISODES AND DIZZINESS, AND EXPERIENCED SHOCK. THE PATIENT WAS SUBSEQUENTLY REFERRED FOR CARDIAC CATHETERIZATION. THE 95% STENOSED, 20MM X 3.0MM, TARGET LESION WAS AN IN-STENT RESTENOTIC LESION LOCATED IN A PREVIOUSLY PLACED 2.75 X 8 MM PROMUS DRUG ELUTING STENT IN THE DISTAL OR MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE TARGET LESION WAS TREATED WITH DIRECT STENT PLACEMENT USING A 2.50 X 24 MM ION COA STENT. FOLLOWING PLACEMENT OF THE ION COA STENT, THE STENT DID NOT APPEAR TO BE COMPLETELY DEPLOYED AND BALLOON DILATATION WAS PERFORMED. AS THERE WAS STILL AN AREA OF RESTENOSIS, AN IVUS CATHETER WAS PLACED DISTAL TO THE STENTS AND PULLED BACK TO ACHIEVE EXCELLENT APPOSITION. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. THREE DAYS LATER, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT AFTER PLACEMENT OF THE ION COA STENT, A 3.0 X 12MM NC APEX BALLOON WAS INFLATED BOTH DISTALLY AND PROXIMALLY. THE STENT APPEARED TO BE WAISTED SO A 3.25 X 12MM NC APEX BALLOON WAS ALSO INFLATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12521 ION? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902424250 14830930

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R