BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2944061 · Received February 5, 2013

    Report

    Report Number
    2134265-2013-01043
    Event Type
    Injury
    Date Received
    February 5, 2013
    Report Date
    January 31, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). IF IMPLANTED, GIVE DATE: 2001. DEVICE EVALUATED BY MANUFACTURER: 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)(6). IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED RESTENOSIS. IN 2001 THE PATIENT HAD A UNKNOWN TAXUS STENT IMPLANTED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AS TREATMENT FOR RESTENOSIS OF AN PREVIOUSLY PLACED UNKNOWN STENT. (B)(6) 2008- THE PATIENT HAD IN STENT RESTENOSIS OF THE PREVIOUSLY PLACED STENT IN 2001 WHICH WAS TREATED WITH PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48973 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE UNK432

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention