BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY ST

    MDR report key: 772083 · Received October 19, 2006

    Report

    Report Number
    6000093-2006-02130
    Event Type
    Injury
    Date Received
    October 19, 2006
    Date of Event
    September 14, 2006
    Report Date
    September 25, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT. SHOULD FURTHER RELEVANT INFORMATION BECOME AVAILABLE; A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    CLINICAL STUDY #3003-002 A-P; SAME CASE AS 6000089-2006-02279, 02280, AND 6000093-2006-02129. IT WAS REPORTED THAT RIGHT AFTER A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE PATIENT HAD AN ACUTE STENT THROMBOSIS (ST). THE INDEX PROCEDURE TREATED A 2.5X23MM, 100% STENOSED LESION IN THE RAMUS INTERMEDIUS ARTERY WITH PLACEMENT OF 4 OVERLAPPING TAXUS EXPRESS2 DRUG ELUTING STENTS OF SIZE 2.25X24MM, 2.5X12MM, 2.5X8MM, 2.25X8MM. CONCOMITANT MEDICATIONS INCLUDE HEPARIN, ASPIRIN AND CLOPIDOGREL. BETA BLOCKER WAS ADMINISTERED IMMEDIATELY AFTER THE INDEX PROCEDURE. THIRTY MINUTES POST PROCEDURE, THE PATIENT DEVELOPED CHEST PAIN. ECG SHOWED ST ELEVATION IN LEADS I AND AVL. STENT THROMBOSIS WAS FOUND IN THE 2.25X24MM STENT IN THE RAMUS WHICH WAS THE INFARCTION-RELATED VESSEL. THERE WAS ALSO ATRIAL FIBRILLATION. THE THROMBOSIS WAS REMOVED WITH EXPORT CATHETER. POST DILATION WAS PERFORMED WITHOUT DISSECTION. THE FLOW WAS RESTORED TO TIMI III. THE PATIENT'S CHEST PAIN WAS RELIEVED AND WAS DISCHARGED IN GOOD CONDITION 6 DAYS LATER ON ACE INHIBITOR, STATIN, ASPIRIN, CLOPIDOGREL AND BETA BLOCKER. IN THE OPINION OF THE PHYSICIAN THE RELATIONSHIP OF THE ST TO THE TAXUS STENT WAS POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY ST DRUG COATED STENT NIQ BOSTON SCIENTIFIC 2.25 X 8MM 7784802

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| O| R