BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION?

    MDR report key: 3895347 · Received June 25, 2014

    Report

    Report Number
    2134265-2014-03590
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    March 27, 2013
    Report Date
    May 30, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 MDR ID: 2134265-2014-03589. (B)(4) STUDY. IT WAS REPORTED THAT MYOCARDIAL INFARCTION (MI) OCCURRED. IN (B)(6) 2012, THE PATIENT PRESENTED DUE TO UNSTABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE INDEX PROCEDURE WAS PERFORMED. TARGET LESION #1 WAS A DE-NOVO LESION LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA) WITH 90% STENOSIS AND WAS 16 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75 MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.75 MM X 16 MM ION¿ STENT WITH 0% RESIDUAL STENOSIS. TARGET LESION #2 WAS A DE NOVO LESION LOCATED IN THE SAPHENOUS VEIN GRAFT (SVG) TO MID RCA WITH 70% STENOSIS AND WAS 20 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. THE LESION WAS TREATED WITH DIRECT STENT PLACEMENT OF A 3.50 MM X 20 MM ION¿ STENT WITH 0% RESIDUAL STENOSIS. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2013, THE PATIENT WAS PRESENTED DUE TO MI AND WAS HOSPITALIZED. NO ECG WAS PERFORMED AND NO LAB ENZYMES WERE DRAWN. DURING THE SAME HOSPITALIZATION, THE SUBJECT WAS DIAGNOSED WITH UNKNOWN MEDICAL DIAGNOSIS WHICH RESULTED IN PROLONGATION OF HOSPITALIZATION. IN (B)(6) 2013, THE EVENT WAS CONSIDERED TO BE RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371628 ION? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902416270 14838796

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization