BEUDAMED
    FDA Adverse Event Death Summary report: N

    ION?

    MDR report key: 3872768 · Received June 13, 2014

    Report

    Report Number
    2134265-2014-03259
    Event Type
    Death
    Date Received
    June 13, 2014
    Date of Event
    August 28, 2013
    Report Date
    May 19, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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

    (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, THE PATIENT EXPIRED. IN (B)(6) 2012, THE PATIENT PRESENTED WITH SYMPTOMS OF UNSTABLE ANGINA (BRAUNWALD CLASSIFICATION IIB) AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (MID LAD) WITH 80% STENOSIS AND WAS 10MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5MM. THE TARGET LESION WAS TREATED WITH PRE-DILATION AND PLACEMENT OF A 2.50X12MM ION STENT, WITH 0% RESIDUAL STENOSIS FOLLOWING POST-DILATION. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2013, THE SITE REPORTED THAT THE PATIENT DIED. PER PHYSICIAN NOTE THE CAUSE OF DEATH IS UNKNOWN AND NO OTHER DOCUMENTS ARE AVAILABLE EXCEPT THE PATIENT¿S ONLINE OBITUARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349874 ION? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902312250 0014489935

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Death