BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 3232524 · Received July 18, 2013

    Report

    Report Number
    2134265-2013-04759
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 19, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. IF IMPLANTED, GIVE DATE: 2006. 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

    IT WAS REPORTED POST A STENTING TREATMENT PROCEDURE IN-STENT RESTENOSIS OCCURRED. IN 2006, THE UNSPECIFIED TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. THE TARGET LESION WAS TREATED WITH A TAXUS EXPRESS 2 STENT. IN (B)(6) 2013, THE PATIENT PRESENTED WITH UNSTABLE ANGINA AND RESTENOSIS WAS FOUND ON THE PREVIOUSLY IMPLANTED TAXUS EXPRESS 2 STENT. ANOTHER STENT WAS IMPLANTED FOR TREATMENT. NO COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334962 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY UNK432

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention