BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION¿

    MDR report key: 2895249 · Received January 3, 2013

    Report

    Report Number
    2134265-2012-08137
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    October 20, 2011
    Report Date
    December 7, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(4). 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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME PATIENT AS MFR#: 2134265-2012-06346, 2134265-2012-06347 AND 2134265-2012-06345. (B)(4). IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, VESSEL DISSECTION OCCURRED. IN (B)(6) 2011, THE PATIENT PRESENTED DUE TO UNSTABLE ANGINA (BRAUNWALD CLASS UNKNOWN) AND CARDIAC CATHETERIZATION WAS RECOMMENDED. THE 1ST DE NOVO OSTIAL LONG TARGET LESION WAS LOCATED IN THE SAPHENOUS VEIN GRAFT EXTENDING FROM 1ST OBTUSE MARGINAL BRANCH (OM) TO 3RD OM WITH 90% STENOSIS AND WAS 6MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATION AND PLACEMENT OF A 3.50X16MM ION STENT, WITH 0% RESIDUAL STENOSIS. THE 2ND DE NOVO TARGET LESION WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (DIST RCA) WITH 90% STENOSIS AND WAS 15MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATION AND PLACEMENT OF A 2.25X28MM ION STENT, WITH 0% RESIDUAL STENOSIS. THE 3RD DE NOVO OSTIAL TARGET LESION WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (PROX RCA) WITH 80% STENOSIS AND WAS 10MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5MM. THE PHYSICIAN TREATED THE LESION WITH DIRECT PLACEMENT OF A 2.50X16MM ION STENT, WITH 20% RESIDUAL STENOSIS. THERE WAS AN EDGE DISSECTION NOTED DISTALLY AFTER THE STENT PLACEMENT. SITE CONFIRMED THAT THIS DISSECTION IS NOT > C. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3083 ION¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902316250 14432214

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other