BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2771156 · Received October 3, 2012

    Report

    Report Number
    2134265-2012-06233
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    August 31, 2012
    Report Date
    September 5, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4). 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).

    Additional Manufacturer Narrative · 1

    IF IMPLANTED, GIVE DATE - CORRECTED FROM (B)(6) 2012 TO (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT IN (B)(6 2010, POST PROCEDURE RESIDUAL STENOSIS WAS 0% WITH TIMI III FLOW. THE PATIENT RECEIVED A PERI-PROCEDURAL LOADING DOSE OF THE THIENOPYRIDINE MEDICATION PRASUGREL 60MG. THE NEXT DAY, THE PATIENT RECEIVED THE STUDY MEDICATION MAINTENANCE DOSE OF PRASUGREL 10MG AND WAS STARTED ON ASPIRIN 325MG. THE PATIENT WAS DISCHARGED THE SAME DAY.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT POST CORONARY STENTING TREATMENT PROCEDURE, STENT THROMBOSIS AND MYOCARDIAL INFARCTION OCCURRED.

    Description of Event or Problem · 1

    (B)(6) CLINICAL STUDY.IT WAS REPORTED THAT POST CORONARY STENTING TREATMENT PROCEDURE, TARGET VESSEL REVASCULARIZATION WAS PERFORMED.ON AN UNKNOWN DATE, THE SUBJECT HAD A 2.25 X 20MM TAXUS LIBERTE STENT PLACED IN THE FIRST DIAGONAL.IN (B)(6) 2012, THE SUBJECT HAD ANGIOGRAPHY. REVASCULARIZATION OF THE FIRST DIAGONAL WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE UNK433

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention