BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® EXPRESS²®

    MDR report key: 2920051 · Received January 17, 2013

    Report

    Report Number
    2134265-2013-00075
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    November 29, 2012
    Report Date
    December 21, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATION 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 MDR ID# 2134265-2013-00076. (B)(4). IT WAS REPORTED THAT POST A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, THE PATIENT EXPERIENCED ANGINA. IN (B)(6) 2008 THE 75% STENOSED AND 15MM LONG DE-NOVO TARGET LESION WAS LOCATED IN THE OSTIUM AND PROXIMAL RIGHT CORONARY ARTERY WITH A REFERENCE VESSEL DIAMETER OF 3.50MM. THE FIRST TARGET LESION WAS TREATED WITH PRE-DILATION USING A 3.0X15MM UNKNOWN MANUFACTURE'S BALLOON THAT WAS INFLATED TO 6ATMS. THE 3.5X20MM TAXUS EXPRESS2 STENT WAS EXPANDED AT 16ATMS. TAXUS EXPRESS2 STENT WAS POST-DILATED WITH A 4.5X8MM UNKNOWN MANUFACTURE'S BALLOON AT 12ATMS, RESULTING IN 0% RESIDUAL STENOSIS AND A TIMI FLOW OF 3 FOLLOWING IVUS. IT WAS NOTED THAT THE STENT WAS WELL EXPANDED. THE 90% STENOSED AND 10.0MM LONG DE-NOVO SECOND TARGET LESION WAS LOCATED IN THE MID DISTAL RIGHT CORONARY ARTERY WITH A REFERENCE VESSEL DIAMETER OF 3.50MM. THE SECOND TARGET LESION WAS TREATED WITH PRE-DILATION USING A 3.0X15MM UNKNOWN MANUFACTURE'S BALLOON THAT WAS INFLATED TO 6ATMS. THE 3.5X15MM TAXUS EXPRESS2 STENT WAS EXPANDED AT 8ATMS, RESULTING IN 0% RESIDUAL STENOSIS AND A TIMI FLOW OF 3 FOLLOWING IVUS. IT WAS NOTED THAT THE STENT WAS WELL EXPANDED. IN (B)(6) 2012 THE PATIENT RETURNED FOR A FOLLOW UP APPOINTMENT AND ANGINA SYMPTOMS WERE NOTED. ITS UNSPECIFIED HOW THE PATIENT WAS TREATED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25472 TAXUS® EXPRESS²® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493897020350 11151847

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other