BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1832192 · Received September 13, 2010

    Report

    Report Number
    2134265-2010-04211
    Event Type
    Injury
    Date Received
    September 13, 2010
    Date of Event
    February 16, 2010
    Report Date
    August 20, 2010
    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT.DEVICE EVALUATED BY MFR: 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

    IT WAS FURTHER REPORTED THAT POST INDEX PROCEDURE THE PATIENT WAS DISCHARGED ON PANALDINE, BAYASPIRIN, WARFARIN, AND WARFARIN POTASSIUM. IT WAS INITIALLY REPORTED THAT THE INDEX LESION WAS 2.22MM IN DIAMETER WITH 66% STENOSIS AND 12% RESIDUAL STENOSIS FOLLOWING TREATMENT. CORRECTED INFORMATION RECEIVED INDICATED THAT THE INDEX PROCEDURE LESION WAS 3.0MM IN DIAMETER WITH 90% STENOSIS WITH 0% RESIDUAL STENOSIS FOLLOWING TREATMENT. IT WAS INITIALLY REPORTED THAT THE REINTERVENTION LESION WAS 2.23MM IN DIAMETER WITH 96% STENOSIS AND 5% RESIDUAL STENOSIS FOLLOWING TREATMENT. CORRECTED INFORMATION RECEIVED INDICATED THE REINTERVENTION LESION WAS 3.0MM IN DIAMETER WITH 99% STENOSIS AND 0% RESIDUAL STENOSIS FOLLOWING TREATMENT.

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #:2134265-2010-04207, 2134265-2010-04208, 2134265-2010-04212. SAME PATIENT AS MFR REPORT #: 2134265-2009-01085, 2134265-2009-01086, 2134265-2009-01087. (B)(4). IT WAS REPORTED THAT FOLLOWING A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT DEVELOPED RESTENOSIS. THE INDEX PROCEDURE TREATED THE OSTIAL, DE NOVO, 2.22X70MM, 66% STENOSED LESION LOCATED IN THE MODERATELY TORTUOUS, SEVERELY CALCIFIED LAD (LEFT ANTERIOR DESCENDING) ARTERY. TREATMENT CONSISTED OF PREDILATION WITH TWO 2.59X30MM BALLOONS AT 8 ATM, PLACEMENT OF THREE OVERLAPPING TAXUS EXPRESS2 DRUG ELUTING STENTS (TWO 3.0X32MM AT 14 ATM EACH AND ONE 3.0X16MM AT 16 ATM), AND POST DILATION RESULTING IN 12% RESIDUAL STENOSIS. THE STENTS WERE REPORTED TO BE WELL POSITIONED AND WELL EXPANDED. ADDITIONALLY, ANOTHER MANUFACTURER'S BARE METAL STENT WAS PLACED IN THE 1ST DIAGONAL DURING THIS PROCEDURE. THE PATIENT WAS DISCHARGED TWO DAYS POST PROCEDURE. IN (B)(6) 2008, THE PROXIMAL LAD HAD 81 TO 56% STENOSIS AND WAS TREATED WITH BALLOON ANGIOPLASTY AND AN UNKNOWN SIZE TAXUS EXPRESS2 STENT. THE PATIENT RETURNED IN (B)(6) 2010 WITH HEART FAILURE SYMPTOMS AND WAS HOSPITALIZED. ANGIOGRAPHY SEVEN DAYS POST ADMISSION SHOWED A 96% RESTENOTIC, 2.23X10MM LESION OF THE MID LAD. TREATMENT 14 DAYS POST ADMISSION CONSISTED OF BALLOON ANGIOPLASTY RESULTING IN 5% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED ON DAY 16. THE EVENT WAS ASSESSED AS POSSIBLY RELATED TO THE STUDY STENTS. AT THE TWO YEAR STUDY FOLLOW UP IN (B)(6) 2010 THE PATIENT HAD NO ANGINA SYMPTOMS.

    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 H7493897032300 0009737656

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R