BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 2830571 · Received November 13, 2012

    Report

    Report Number
    2134265-2012-07033
    Event Type
    Injury
    Date Received
    November 13, 2012
    Date of Event
    October 10, 2012
    Report Date
    October 15, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). 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). IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, A STENT WAS FOUND TO BE PROTRUDING. IN (B)(6) 2012, THE PATIENT PRESENTED WITH A NON-Q WAVE MYOCARDIAL INFARCTION. THE 75% STENOSED TARGET LESION IN THE OSTIAL LEFT MAIN CORONARY ARTERY (LMCA) WAS TREATED WITH AN ION MONORAIL STENT. NO ISSUES WERE NOTED DURING THE PROCEDURE AND THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2012, THE PATIENT PRESENTED WITH ABDOMINAL PAIN, DIARRHEA, CHEST PAIN, NON-ST ELEVATION MI AND HYPERTENSIVE URGENCY. THE PATIENT WAS FOUND TO HAVE CRITICAL AORTIC STENOSIS. AORTIC VALVE REPLACEMENT WAS INDICATED. DURING AN AORTIC VALVE REPLACEMENT AND REDO CORONARY ARTERY BYPASS GRAFT TO THE POSTERIOR DESCENDING ARTERY, IT WAS NOTED THAT THE PREVIOUSLY PLACED ION MONORAIL STENT IN THE LMCA WAS PROTRUDING APPROXIMATELY 1 MM. THE PROTRUDING STENT WAS PROTECTED DURING TREATMENT BY INSERTING AN ANGIOPLASTY BALLOON INTO THE STENT. POST TREATMENT, THE PATIENT'S STATUS WAS CRITICAL BUT STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE UNK692

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention