BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2944063 · Received February 5, 2013

    Report

    Report Number
    2134265-2013-01044
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    February 3, 2011
    Report Date
    January 31, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS COMBINATION PRODUCT. IF IMPLANTED, GIVE DATE: 2001. 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

    (B)(6). IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED CHEST PAIN, DYSPNEA, UNSTABLE ANGINA AND RESTENOSIS. SOMETIME IN 2001 THE PATIENT HAD A UNKNOWN STENT IMPLANTED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AS TREATMENT FOR RESTENOSIS OF AN PREVIOUSLY PLACED UNKNOWN STENT. (B)(6) 2011 - THE PATIENT PRESENTED WITH CHEST PAIN, DYSPNEA ON EXERTION AND HIGH BLOOD PRESSURE AT NIGHT AND WAS DIAGNOSED WITH UNSTABLE ANGINA. (B)(6) 2011 -THE 80% IN STENT RESTENOSED TARGET LESION WAS 36 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0 MM, LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) EXTENDING INTO THE MID LAD. THE PHYSICIAN TREATED THE LESION WITH DIRECT STENT PLACEMENT USING A 3.0 X 38 MM TAXUS LIBERTE STENT. FOLLOWING POST DILATATION WITH AN UNKNOWN BALLOON CATHETER, RESIDUAL STENOSIS WAS 15%. IN ADDITION THE 75% IN-STENT RESTENOSIS OF AN UNKNOWN STENT LOCATED IN THE LEFT CIRCUMFLEX (LCX) OBTUSE MARGINAL (OM) WAS TREATED WITH BALLOON ANGIOPLASTY, WITH LESS THAN 10% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND PRASUGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48469 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE UNK432

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention