BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 3193215 · Received June 27, 2013

    Report

    Report Number
    2134265-2013-04476
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    March 26, 2012
    Report Date
    May 31, 2013
    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. 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) CLINICAL STUDY. IT WAS REPORTED THAT SUBSEQUENT TO A STENTING TREATMENT PROCEDURE, A RESTENOSIS OCCURRED. IN (B)(6) 2008, A LESION LOCATED IN THE DISTAL SEGMENT OF RIGHT CORONARY ARTERY WAS TREATED WITH A PLACEMENT OF TAXUS EXPRESS DRUG-ELUTING STENT. ON (B)(6) 2012, THE 100% IN-STENT RESTENOSIS LESION OF A TAXUS EXPRESS DRUG-ELUTING STENT WAS LOCATED IN THE DISTAL SEGMENT OF RIGHT CORONARY ARTERY WITH A REFERENCE VESSEL DIAMETER OF 3.0MM. IT WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A NON-BSC STENT. FOLLOWING PRE-DILATATION, RESIDUAL STENOSIS WAS 0%. TWO DAYS AFTER, THE SUBJECT RECOVERED AND THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS. IN SEPTEMBER 2012, A 4-YEAR FOLLOW-UP WAS PERFORMED AND NO ANGINA PECTORIS WAS CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294495 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY UNK432

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R