BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 3232646 · Received July 18, 2013

    Report

    Report Number
    2134265-2013-04756
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 28, 2011
    Report Date
    June 20, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATION. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    (B)(4). SAME CASE AS MDR #2134265-2013-04915. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, IN-STENT RESTENOSIS OCCURRED. IN MARCH 2008, THE PATIENT WAS DIAGNOSED WITH STABLE ANGINA (CCS CLASS:3) AND CARDIAC CATHETERIZATION WAS RECOMMENDED. THE 85% STENOSED, 12 X 2.75MM, TARGET LESION WAS LOCATED IN THE 1ST OBTUSE MARGINAL BRANCH (OM). THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.75 X 16 MM STUDY STENT, WITH 0% RESIDUAL STENOSIS. IN ADDITION, A 60% STENOSED, 15 X 2.5MM, NON-TARGET LESION LOCATED IN 2ND OM WAS TREATED WITH PLACEMENT OF A 3.00 X 20 MM TAXUS EXPRESS 2 STENT. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN JUNE 2011, THE PATIENT PRESENTED WITH SYNCOPE AND WAS HOSPITALIZED. THE 80% IN-STENT RESTENOSIS OF THE PREVIOUSLY PLACED STUDY STENT IN 1ST OM WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF A 2.75 X 15MM NON-BSC DRUG ELUTING STENT WITH 0% RESIDUAL STENOSIS. IN ADDITION, THE 80% IN-STENT RESTENOSIS OF THE PREVIOUSLY PLACED TAXUS EXPRESS 2 STENT IN THE 2ND OM WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF TWO NON-BSC DRUG ELUTING STENTS, 3.00 X 12 MM AND 3.00 X 8 MM, WITH 0% RESIDUAL STENOSIS. THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334608 ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE UNK692 11068829

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R