BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 4003302 · Received August 12, 2014

    Report

    Report Number
    2134265-2014-04611
    Event Type
    Injury
    Date Received
    August 12, 2014
    Date of Event
    April 4, 2011
    Report Date
    July 14, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. 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

    SAME CASE AS MFR: 2134265-2014-04613. (B)(4). IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED STENT THROMBOSIS AND SUBSEQUENT MYOCARDIAL INFARCTION. IN (B)(6) 2011, THE PATIENT PRESENTED WITH UNSTABLE ANGINA, BRAUNWALD CLASSIFICATION- IIIB, WHICH WAS DIAGNOSED AS A MYOCARDIAL INFARCTION (MI). CORONARY ANGIOGRAPHY REVEALED STENT THROMBOSIS OF AN UNSPECIFIED BSC STENT IN THE OSTIAL LEFT ANTERIOR DESCENDING (LAD) ARTERY AND A TOTAL OCCLUSION OF AN UNSPECIFIED BSC STENT IN THE MID LAD. TARGET LESION #1 WAS A BIFURCATED, TOTAL OCCLUSION LOCATED WITHIN THE BSC STENT IN THE MID LAD. THE LESION WAS 12MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5MM. THIS LESION WAS TREATED WITH THROMBOSUCTION, PRE-DILATATION AND PLACEMENT OF A 2.50 MM X 16 MM PROMUS ELEMENT STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. TARGET LESION #2 WAS A TOTAL OCCLUSION LOCATED WITHIN THE BSC STENT IN THE PROXIMAL LAD. THE LESION WAS 20MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0MM. THIS LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.00 MM X 20 MM PROMUS ELEMENT STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 10%. THREE DAYS POST PROCEDURE THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479820 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY UNK433

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention