BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 797952 · Received December 20, 2006

    Report

    Report Number
    6000089-2006-02614
    Event Type
    Injury
    Date Received
    December 20, 2006
    Date of Event
    February 7, 2006
    Report Date
    December 6, 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
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    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 ASSEMBLY NAMELY TOP ASSEMBLY BATCH # 7012318 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

    CLINICAL TRIAL. SAME CASE AS MFR# 6000089-2006-02615. IT WAS REPORTED THAT POST INDEX PROCEDURE THE PATIENT HAD A TARGET VESSEL REVASCULARIZATION (TVR). THE INDEX PROCEDURE TREATED A BIFURCATED LESION IN THE RIGHT POSTERIOR DESCENDING ARTERY (R-PDA) AND 1ST RIGHT POSTERIOR LATERAL ARTERY (RPL). THE VESSEL WAS 2.5 MM WIDE, 24 MM LONG AND 80% STENOSED. THE PHYSICIAN PREDILATED THE LESION PRIOR TO PLACING OVERLAPPING STENTS - A 2.5 X 24MM TAXUS EXPRESS2 AS WELL AS A 2.5 X 8 MM TAXUS EXPRESS. 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 426, THE PATIENT HAD A TVR TO THE DISTAL RIGHT CORONARY ARTERY (RCA). ANOTHER MANUFACTURER'S STENT WAS PLACED AND THE PATIENT WAS DISCHARGED ONE DAY LATER. IN THE OPINION OF THE PHYSICIAN, THERE WAS NO RELATIONSHIP BETWEEN THE TAXUS STENT AND THE TVR.

    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 8 MM 7012318

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| L| R