BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2102867 · Received May 25, 2011

    Report

    Report Number
    2134265-2011-01959
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    January 12, 2011
    Report Date
    April 28, 2011
    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 EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING A STENTING TREATMENT PROCEDURE, THE PATIENT PRESENTED WITH IN STENT RESTENOSIS. THE INDEX PROCEDURE TREATED THE TYPE B1, 75% STENOSED 2.75X25MM TARGET LESION LOCATED IN THE DISTAL LEFT CIRCUMFLEX (LCX) ARTERY. TREATMENT CONSISTED OF THE PLACEMENT OF A 2.75X28MM TAXUS EXPRESS2 STENT DEPLOYED AT 16 ATM'S USING A DIRECT STENT TECHNIQUE AND POST DILATION WITH 2.75X15 UNSPECIFIED BALLOON AT 26 ATM'S RESULTING IN 0% RESIDUAL STENOSIS. IN (B)(6) 2011, ANGIOGRAPHY REVEALED A 75% STENOSED, 2.5X28 LESION IN THE DISTAL LCX. TREATMENT PLACED A NON BSC STENT RESULTING IN 0% RESIDUAL STENOSIS. TWO DAYS LATER THE PATIENT HAD NO ANGINAL SYMPTOMS. THE PHYSICIAN LISTED THE EVENT AS POSSIBLY RELATED TO THE STUDY STENT.

    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 - MAPLE GROVE H7493897028270 9794729

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention