BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 799686 · Received December 21, 2006

    Report

    Report Number
    6000089-2006-02620
    Event Type
    Injury
    Date Received
    December 21, 2006
    Date of Event
    November 26, 2006
    Report Date
    December 4, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    H6. A UNIT HAS NOT BEEN RETURNED FOR REVIEW THEREFORE A TECHNICAL ANALYSIS CANNOT BE CARRIED OUT. WITHOUT A RETURNED UNIT, IT IS NOT POSSIBLE TO CONFIRM HOW THE DEVICE MAY HAVE CONTRIBUTED TO THE COMPLAINT INCIDENT. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS PARTICULAR BATCH NAMELY TOP ASSEMBLY BATCH # 6973183 FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS, AT THE TIME OF RELEASE TO DISTRIBUTION. THE ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    SAME CASE AS MFR# 6000089-2006-02621. IT WAS REPORTED THAT POST INDEX PROCEDURE, THE PATIENT HAD A MYOCARDIAL INFARCTION (MI) AND A TARGET VESSEL REVASCULARIZATION (TVR). THE PATIENT PRESENTED TO THE INDEX PROCEDURE WITH AN ACUTE MI. THE INDEX PROCEDURE TREATED A DE NOVO LESION IN THE DISTAL CIRCUMFLEX (CX). THE LESION WAS 2.4 MM WIDE, 39 MM LONG, AND 100% STENOSED. THERE WAS MILD CALCIFICATION AND MODERATE TORTUOUSITY. THE PHYSICIAN PREDILATED THE LESION PRIOR TO PLACING 2 OVERLAPPING 2.5 X 24 MM TAXUS EXPRESS2 STENTS. RESIDUAL STENOSIS WAS 0%. THE PATIENT RECEIVED A GPIIB/IIIA INHIBITOR AND PLAVIX DURING THE PROCEDURE. THE PATIENT WAS DISCHARGED ONE DAY LATER ON ASPIRIN AND PLAVIX. ON DAY 743, THE PATIENT PRESENTED WITH A NON Q-WAVE MI (NQMI). TO RESOLVE THE EVENT, THE PATIENT UNDERWENT A TVR TO THE DISTAL CX FOR DISTAL EDGE IN-STENT RESTENOSIS. THE EVENTS WERE CONSIDERED RESOLVED THE NEXT DAY AND THE PATIENT WAS DISCHARGED. IN THE OPINION OF THE PHYSICIAN, THERE WAS AN UNKNOWN RELATIONSHIP BETWEEN THE MI AND THE TAXUS STENT, BUT A PROBABLE RELATIONSHIP BETWEEN THE MI AND TARGET VESSEL. IN THE OPINION OF THE PHYSICIAN , THERE WAS A PROBABLE RELATIONSHIP BETWEEN THE TVR AND THE TAXUS STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM NIQ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC CORP. 2.5 X 24 MM 6973183

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| L| R