BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT

    MDR report key: 762477 · Received September 18, 2006

    Report

    Report Number
    6000089-2006-02030
    Event Type
    Injury
    Date Received
    September 18, 2006
    Date of Event
    October 7, 2005
    Report Date
    August 21, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE STENT REMAINS IN THE PT AND THE DELIVERY DEVICE HAS BEEN DISPOSED; THEREFORE, NO DIRECT PRODUCT ANALYSIS WILL BE AVAILABLE. THE SHOP FLOOR PAPERWORK FOR THIS BATCH SHOWS THAT THE PRODUCT MET ITS SPECIFICATIONS. A REVIEW OF THE MFG RECORD FOR THIS PARTICULAR BATCH SHOWS THE DEVICE MET ITS MATERIAL, ASSEMBLY & PRODUCT SPECIFICATIONS. AS NO DEVICE WAS RECEVIED FOR ANALYSIS, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE DIFFICULTIES EXPERIENCED WITH THIS COMPLAINT INCIDENT.

    Description of Event or Problem · 1

    CLINICAL STUDY. SAME CASE AS 6000089-2006-02029. IT WAS REPORTED THAT 233 DAYS AFTER A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE PT REQUIRED A TARGET VESSEL REINTERVENTION (TVR). LESION 1 WAS A 3.5MM, 80% STENOSED, 6MM PORTION OF THE MID RIGHT CORONARY ARTERY (MID RCA). THE PHYSICIAN TREATED THE LESION WITH PREDILATATION AND SUCCESSFUL PLACEMENT OF A TAXUS EXPRESS2 8.8% 3.50X16MM DRUG ELUTING STENT IN THE TARGET LESION. LESION 2 WAS A 3.0MM, 100% STENOSED, 25MM LONG PORTION OF THE DISTAL RIGHT CORONARY ARTERY (DIST RCA). THE PHYSICIAN TREATED THE LESION WITH PREDILATATION AND SUCCESSFUL PLACEMENT OF TWO TAXUS EXPRESS2 8.8% (3.00X28MM & 2.50X20MM) DRUG ELUTING STENTS IN THE TARGET LESION WITH A 2MM OVERLAP. THERE WERE NO REPORTED COMPLICATIONS. THE PT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND PLAVIX. TWO HUNDRED AND THIRTY THREE DAYS AFTER THE INITIAL PROCEDURE, THE PT REQUIRED A TVR. THE PHYSICIAN SUCCESSFULLY IMPLANTED A JOHNSON & JOHNSON CYPHER STENT IN THE DIST RCA TO TREAT IN-STENT RESTENOSIS. IN THE OPINION OF THE PHYSICIAN, THE RELATIONSHIP OF THE TVR TO THE TAXUS STENT IS PROBABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT DRUG COATED STENT NIQ BOSTON SCIENTIFIC 3.00X28MM 7180663

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention