BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ® LONG

    MDR report key: 2944055 · Received February 5, 2013

    Report

    Report Number
    2134265-2013-00346
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    August 13, 2012
    Report Date
    January 7, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS 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

    (B)(6). SAME CASE AS MDR ID# 2134265-2012013-01056. (B)(6). IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED CHEST PAIN, DYSPNEA AND UNSTABLE ANGINA. SOMETIME IN 2001 THE PATIENT HAD A UNKNOWN TAXUS 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. (B)(6) 2012 - THE PATIENT PRESENTED WITH CHEST PAIN, DIAGNOSED WITH UNSTABLE ANGINA WITH 2 VESSEL CORONARY ARTERY DISEASE AND WAS HOSPITALIZED ON ASPIRIN AND PRASUGREL. FOUR DAYS LATER THE PATIENT UNDERWENT CORONARY ARTERY BYPASS GRAFT (CABG) ON THE LEFT INTERNAL MEMMARY ARTERY (LIMA) TO 1ST DIAGONAL AND THE SAPHENOUS VEIN GRAFT (SVG) TO THE 1ST OBTUSE MARGINAL (OM) VESSELS. THE PATIENT WAS ALSO TREATED MEDICALLY DURING THE COURSE OF THE EVENT. THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED FIVE DAYS LATER.

    Description of Event or Problem · 1

    THE EVENT DATE WAS INITIALLY REPORTED INCORRECTLY TO HAVE TAKEN PLACE IN (B)(6) 2012, THE EVENT TOOK PLACE IN (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48972 TAXUS® LIBERTÉ® LONG CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893638300 13568510

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R