BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION¿

    MDR report key: 2893650 · Received January 2, 2013

    Report

    Report Number
    2134265-2012-08115
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    December 3, 2012
    Report Date
    December 6, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: 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

    (B)(4). SAME CASE AS 2134265-2012-08110. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE THE PATIENT EXPERIENCED RESTENOSIS. THE TARGET LESION WAS A DE NOVO LESION LOCATED IN THE 3RD OBTUSE MARGINAL (OM) WITH 99% STENOSIS AND WAS 8 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25 MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND PLACEMENT OF 2.25 MM X 12 MM AND 2.25 MM X 12 MM ION STENTS IN AN OVERLAPPING MANNER. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2012, THE PATIENT PRESENTED DUE TO UNSTABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION AND RESTENOSIS WAS DISCOVERED. THE 99% FOCAL IN-STENT RESTENOSIS LOCATED IN THE 3RD OM WAS TREATED WITH BALLOON ANGIOPLASTY WITH 10% RESIDUAL STENOSIS. ADDITIONALLY THE 80% STENOSIS LOCATED IN THE DISTAL LEFT CIRCUMFLEX WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF A DRUG ELUTING STENT WITH 0% RESIDUAL STENOSIS. THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127 ION¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902412220 14426803

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention 2.25X12MM ION STENT