BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2020277 · Received March 16, 2011

    Report

    Report Number
    2134265-2011-00633
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    March 5, 2010
    Report Date
    February 15, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM, PATIENT SEX, DATE OF BIRTH, UPN, CATALOG.MODEL #, IMPLANT DATE, OTHER RELEVANT HISTORY, PATIENT CODE, THERAPY DATES AND DESCRIPTIONS: UPDATED.OUTCOMES ATTRIBUTED TO (B)(4) CORRECTED FROM OTHER TO REQUIRED INTERVENTION.(B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR#: 2134265-2011-02215. IT WAS FURTHER REPORTED: IN (B)(6) 2008 A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED TO TREAT TWO LESIONS. THE FIRST LESION LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX ARTERY HAD A REFERENCE VESSEL DIAMETER OF 2.60MM AND LENGTH OF 12.9MM AND 52% STENOSIS. THE LESION WAS TREATED WITH PREDILATATION AND DEPLOYED A 2.75X12MM TAXUS EXPRESS2 STENT. POST DILATATION WAS NOT PERFORMED. RESIDUAL STENOSIS WAS 22%. TIMI FLOW IMPROVED FROM 2 TO 3. THE SECOND LESION WAS LOCATED IN THE 2ND OBTUSE MARGINAL BRANCH WITH REFERENCE VESSEL DIAMETER UNKNOWN AND LESION LENGTH 32.6M WITH 99% STENOSIS. THIS WAS TREATED WITH PREDILATATION AND DEPLOYED A 2.50X24MM TAXUS EXPRESS2 STENT AND A 2.50X12MM TAXUS EXPRESS2 STENT AND THEN POST DILATED. RESIDUAL STENOSIS WAS 18%. TIMI FLOW IMPROVED FROM 2 TO 3. A NON BSC STENT WAS DEPLOYED TO TREAT A LESION LOCATED IN THE LEFT MAIN CORONARY ARTERY. THE PATIENT WAS DISCHARGED WITH OUT COMPLICATIONS THE NEXT DAY ON BAYASPIRIN AND TICLOPIDINE.

    Description of Event or Problem · 1

    (B)(6). IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, ISCHEMIA AND ANGINA OCCURRED. A TAXUS EXPRESS2 STENT WAS IMPLANTED IN THE 2ND OBTUSE MARGINAL BRANCH (OM) ON AN UNSPECIFIED DATE. IN (B)(6) 2011, THE PATIENT PRESENTED WITH ANGINA AND ISCHEMIA. A 99% STENOSED LESION WAS IDENTIFIED IN THE 2ND OM AND WAS TREATED WITH BALLOON ANGIOPLASTY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GETTING BETTER.

    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 - GALWAY H7493897024250

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other| R 2.5X12 TAXUS EXPRESS2 STENT