BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION?

    MDR report key: 3162895 · Received June 11, 2013

    Report

    Report Number
    2134265-2013-03935
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    January 23, 2013
    Report Date
    May 13, 2013
    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

    DEVICE IS A COMBINATION PRODUCT. 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)(6) STUDY. SAME PATIENT AS (B)(6). IT WAS REPORTED THAT POST CORONARY STENTING TREATMENT PROCEDURE PSEUDOANEURYSM OCCURRED. IN (B)(6) 2012, THE TARGET LESION # 1 WAS A DE NOVO LESION LOCATED IN THE PROXIMAL LAD WITH 70% STENOSIS AND WAS 22 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0 MM. THE TARGET LESION # 1 WAS TREATED WITH DIRECT STENT PLACEMENT USING A 3.00 MM X 24 MM (B)(6) STENT. FOLLOWING POST DILATATION THE RESIDUAL STENOSIS WAS 0 %. POST DEPLOYMENT OF THE 3.0 X 24 MM (B)(6) STENT THERE WAS JAILING NOTED IN THE DIAGONAL BRANCH. BALLOON ANGIOPLASTY WAS THEN PERFORMED AT THE OSTIUM OF THE DIAGONAL USING A 2.0 X 12 MM MAVERICK BALLOON. THE PATIENT WAS DISCHARGED ONE DAY POST PROCEDURE ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2013, THE SUBJECT HAD BEEN EXPERIENCING INTERMITTENT EPISODES OF CHEST TIGHTNESS WHICH WAS SUBSEQUENTLY DIAGNOSED AS ANGINA PECTORIS. THIS WORSENED WHILE LYING FLAT FOR THE LAST FEW WEEKS. THE SUBJECT WAS HOSPITALIZED ON THE SAME DAY. THE PATIENT HAD PLEURAL EFFUSION FOR WHICH HE UNDERWENT IR TUBE REPLACEMENT AND DRAINAGE. THE SUBJECT UNDERWENT CABG X 2: SVG TO PROXIMAL LAD; LIMA TO 1ST DIAGONAL. INCIDENTALLY, THE PSEUDOANEURYSM IN THE PROXIMAL LAD WAS ISOLATED AND CLOSED WITH A PLEDGETED HORIZONTAL MATRIX SUTURE. IN (B)(6) 2013, THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE SUBJECT WAS DISCHARGED ON THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262896 ION? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902424300 14781252

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention