BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2880265 · Received December 19, 2012

    Report

    Report Number
    2134265-2012-08014
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    June 7, 2011
    Report Date
    November 30, 2012
    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. 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)(4) STUDY. SAME PATIENT AS: 2134265-2009-03516, 2134265-2010-01092, 2134265-2010-01091, 2134265-2010-04272, 2134265-2010- 04517, 2134265-2010-04375, 2134265-2010-04376. SAME CASE AS: 2134265-2012-08011, 2134265-2012-08012, 2134265-2012-08013, 2134265-2012-08010. IT WAS REPORTED THAT POST A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED RESTENOSIS AND UNDERWENT A CORONARY ARTERY BYPASS GRAFT. LESION 1 WAS DE NOVO 75% STENOSED, 3.00MM IN DIAMETER AND 24.0MM LONG PORTION OF MID RIGHT CORONARY ARTERY (RCA). THE LESION WAS PREDILATED WITH AN UNKNOWN BALLOON AT 12 ATMS. A 3.00MMX24MM TAXUS EXPRESS2 STENT WAS IMPLANTED AT 18 ATMS. POST PROCEDURE VISUAL EVALUATION REVEALED 0% STENOSIS AND TIMI FLOW WAS 3. LESION 2 WAS A DE NOVO 90% STENOSED, 3.00MM IN DIAMETER AND 20.0MM LONG PORTION OF THE 1ST RIGHT POSTEROLATERAL (RPL). THE LESION WAS PREDILATED WITH TWO UNKNOWN BALLOONS AT 14 ATMS. A 3.00X24MM TAXUS EXPRESS2 STENT WAS IMPLANTED AT 18 ATMS AND A 2.50X16MM TAXUS EXPRESS2 STENT WAS IMPLANTED AT 10 ATMS IN THE LESION. THE LESION WAS POST DILATED WITH TWO SEPARATE BALLOONS. POST PROCEDURE VISUAL EVALUATION REVEALED 0% STENOSIS AND TIMI FLOW WAS 3. 99 DAYS LATER TARGET VESSEL REINTERVENTION WAS PERFORMED ON THE PROXIMAL AND DISTAL RCA. THE 3.00MM IN DIAMETER, 14.0MM LONG, 75% STENOSED LESION IN THE PROXIMAL RCA WAS TREATED WITH AN UNSPECIFIED BALLOON AND A TAXUS STENT. POST TREATMENT VISUAL INSPECTION REVEALED 0% STENOSIS. THE 3.00MMIN DIAMETER, 15.0MM LONG, 90% STENOSED LESION IN THE DISTAL RCA WAS TREATED WITH AN UNSPECIFIED BALLOON AND A TAXUS STENT. POST TREATMENT VISUAL INSPECTION REVEALED 0% STENOSIS. PATIENT OUTCOME WAS IMPROVED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL 2 DAYS LATER. IN (B)(6) 2011, THE PATIENT EXPERIENCED RESTENOSIS IN THE RIGHT CORONARY ARTERY WITH LEFT MAIN CORONARY ARTERY STENOSIS. IN (B)(6) 2011, A CORONARY ARTERY BYPASS GRAFT WAS PERFORMED. THE PATIENT OUTCOME IMPROVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R