BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 3192875 · Received June 27, 2013

    Report

    Report Number
    2134265-2013-04345
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    June 8, 2012
    Report Date
    May 31, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). 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. THE MANUFACTURING BATCH RECORD REVIEW CONFORMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATION AS THE REPORTED EVENT IS DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE NOTED WITHIN THE PRODUCT DIRECTIONS FOR USE (DFU) AND/OR DEVICE LABELING. (B)(4).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, THE PATIENT HAD MYOCARDIAL INFARCTION (MI). IN (B)(6) 2007, THE PATIENT WAS DIAGNOSED WITH STABLE ANGINA (CCS CLASSIFICATION 3) AND CARDIAC CATHETERIZATION WAS RECOMMENDED. THE TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (MID RCA) WITH 90% STENOSIS AND WAS 12MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.00MM. THE TARGET LESION WAS TREATED WITH PRE-DILATION AND PLACEMENT OF A 3.00X16MM TAXUS PERSEUS STENT, WITH 0% RESIDUAL STENOSIS. IN ADDITION, A NON-TARGET LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY (MID LAD) WITH 90% STENOSIS WAS TREATED WITH A 2.75X20MM TAXUS EXPRESS2 STENT. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2012, THE PATIENT PRESENTED WITH EXERTIONAL CHEST PAIN AND SHORTNESS OF BREATH. THE PATIENT¿S CARDIAC ENZYMES WERE NOTED TO BE ELEVATED. SUBSEQUENTLY, THE PATIENT WAS DIAGNOSED WITH NON Q-WAVE MYOCARDIAL INFARCTION WITH NON ST CHANGES IN ECG AND CARDIAC CATHETERIZATION WAS RECOMMENDED. 80% STENOSIS WAS NOTED IN THE DISTAL RCA WHICH WAS TREATED WITH PLACEMENT OF A 2.5X18MM NON-BSC STENT. THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS. THE PATIENT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293446 ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE UNK692 9517210

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R