BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION?

    MDR report key: 3698576 · Received March 25, 2014

    Report

    Report Number
    2134265-2014-01322
    Event Type
    Injury
    Date Received
    March 25, 2014
    Date of Event
    February 19, 2013
    Report Date
    February 24, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. 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

    (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT IN-STENT RESTENOSIS (ISR) AND CHEST PAIN OCCURRED. IN (B)(6) 2012, THE PATIENT PRESENTED DUE TO CHEST WHICH SHOWED THE EVIDENCE OF ANTERIOR WALL SCHEMIA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. SUBSEQUENTLY, INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION WAS A DE NOVO LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 80% STENOSIS AND WAS 20MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3MM. THE TARGET LESION WAS TREATED WITH DIRECT STENT PLACEMENT USING A 3.00X24MM ION STENT, FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2013, THE PATIENT WAS PRESENTED WITH CHEST PAIN CONCERNING ANGINA AND WAS HOSPITALIZED IN THE SAME DAY. SUBSEQUENTLY CORONARY ANGIOGRAPHY WAS PERFORMED. THE 100% DIFFUSE ISR OF PREVIOUSLY PLACED STUDY STENT LOCATED IN THE MID LAD WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF A 2.5MMX38MM AND 3MMX15MM NON-BSC STENT, WITH 0% RESIDUAL STENOSIS. ONE DAY POST PROCEDURE, THE EVENT WAS CONSIDERED RESOLVED WITHOUT EFFECTS AND THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174742 ION? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902424300 14466601

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R