BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION¿

    MDR report key: 2993102 · Received March 7, 2013

    Report

    Report Number
    2134265-2013-01797
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    November 14, 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
    OH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS 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

    (B)(4) STUDY. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, A MYOCARDIAL INFARCTION AND STENT THROMBOSIS OCCURRED. IN (B)(6) 2011, A 99% STENOSED, 18 X 2.25MM NATIVE TARGET LESION, WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH TIMI PRE FLOW 2. THE TARGET LESION WAS TREATED WITH PRE-DILATION AND IMPLANTATION OF A 20MM X 2.25MM ION STENT. FOLLOWING POST-DILATION THERE WAS 0% RESIDUAL STENOSIS AND TIMI FLOW 3. THE PATIENT WAS DISCHARGED ON PLAVIX AND ASPIRIN. IN (B)(6) 2012, THE PATIENT PRESENTED WITH CHEST TIGHTNESS, SHORTNESS OF BREATH, NAUSEA/VOMITING AND DISPHORESIS. THE PATIENT HAD RECURRENT ISCHEMIC SYMPTOMS LASTING 10 MINUTES OR LONGER AND WAS DIAGNOSED WITH A MYOCARDIAL INFARCTION. ANGIOGRAPHY REVEALED A 90% STENOSED LAD. THE PHYSICIAN DID NOT BELIEVE THIS EVENT WAS RELATED TO THE STUDY STENT AND THE PATIENT WAS DISCHARGED TWO DAYS LATER. FIVE DAYS LATER THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH COMPLAINTS OF CHEST PAIN AND BILATERAL ARM NUMBNESS/TINGLING. CARDIAC CATHEERIZATION REVEALED 100% STENT THROMBOSIS IN THE MID LAD. THE STENT THROMBOSIS WAS TREATED WITH IMPLANTATION OF AN UNSPECIFIED STENT WITH 0% RESIDUAL STENOSIS AND TIMI FLOW 3. THE PATIENT WAS DISCHARGED THREE DAYS LATER. THE PHYSICIAN BELIEVED THE THROMBOSIS WAS POSSIBLY RELATED TO THE STUDY STENT. AT THE TIME OF THIS EVENT THE PATIENT WAS ON ASPIRIN AND EITHER PLAVIX OR A PLACEBO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98102 ION¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902420220 0014020157

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention