BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1884316 · Received October 27, 2010

    Report

    Report Number
    2134265-2010-04888
    Event Type
    Injury
    Date Received
    October 27, 2010
    Date of Event
    January 21, 2010
    Report Date
    October 6, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    (B)(4). SAME CASE AS MFR REPORT #: 2134265-2010-04887. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE THE PATIENT DEVELOPED IN-STENT RESTENOSIS. THE INDEX PROCEDURE TREATED A 100% RESTENOTIC, 3.5X55MM LESION IN THE PROXIMAL LAD (LEFT ANTERIOR DESCENDING). TREATMENT CONSISTED OF PREDILATION WITH TWO BALLOON CATHETERS, PLACEMENT OF TWO OVERLAPPING TAXUS EXPRESS2 STENTS (3.5X28MM AND 2.75X32MM), AND POST DILATED WITH A 3.0X15MM BALLOON CATHETER AT 15 ATM RESULTING IN 0% RESIDUAL STENOSIS. POST TREATMENT IVUS (INTRAVASCULAR ULTRASOUND) SHOWED WELL EXPANDED STENTS. IN (B)(6) 2010 THE PATIENT RETURNED AND IN-STENT RESTENOSIS OF THE PROXIMAL LAD WAS FOUND. THE PATIENT DID NOT PRESENT WITH ISCHEMIC SYMPTOMS. IN (B)(6) 2010 THE 75% STENOSED, 4.0X13MM MID LAD LESION WAS TREATED WITH BALLOON ANGIOPLASTY RESULTING IN 25% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED TWO DAYS LATER. AT THE (B)(6) 2010 STUDY FOLLOW UP THE PATIENT DID NOT HAVE ANGINA SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493897032270

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R