BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 3232621 · Received July 18, 2013

    Report

    Report Number
    2134265-2013-04915
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 28, 2011
    Report Date
    June 20, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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). SAME CASE AS MDR #2134265-2013-04756. 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
    333810 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY UNK432

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R