BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION?

    MDR report key: 3761324 · Received April 21, 2014

    Report

    Report Number
    2134265-2014-02007
    Event Type
    Injury
    Date Received
    April 21, 2014
    Date of Event
    April 17, 2012
    Report Date
    March 25, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A 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).

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2014-02008. (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT VESSEL SPASM OCCURRED. ON (B)(6) 2012, THE PATIENT PRESENTED DUE TO STABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. TARGET LESION #1 WAS A DE-NOVO LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) EXTENDING TO DISTAL LAD WITH 90% STENOSIS AND WAS 28 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3 MM. THE LESION WAS TREATED WITH DIRECT STENT PLACEMENT USING A 2.75 MM X 32 MM ION STENT. FOLLOWING POSTDILATATION RESIDUAL STENOSIS WAS 0%. FOLLOWING STENT DEPLOYMENT AND POST-DILATION WITH A 3 MM X 15 MM QUANTUM APEX BALLOON CATHETER, SPASM OCCURRED. THE PATIENT WAS THEN TREATED WITH 225 MICROGRAMS OF INTRACORONARY NITROGLYCERIN. TEN DAYS POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239361 ION? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902432270 14714766

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention