BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS (R) LIBERTÉ (R)

    MDR report key: 1981789 · Received February 8, 2011

    Report

    Report Number
    2134265-2011-00129
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    July 6, 2010
    Report Date
    January 10, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6). DEVICE IS A COMBINATION PRODUCT. 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 PATIENT AS 2134265-2012-00541. IT WAS FURTHER REPORTED THAT THE PATIENT WAS DISCHARGED FROM THE INDEX PROCEDURE ON ASPIRIN AND PRASUGREL. IN (B)(6) 2010, THE PATIENT PRESENTED WITH SUBSTERNAL CHEST PAIN. ADMISSION ECG SHOWED SINUS RHYTHM AND SERIAL CARIDAC ENZYMES WERE NEGATIVE. MYOCARDIAL PERFUSION IMAGING DEMONSTRATED A SMALL AREA OF REVERSIBLE ANTEROAPICAL ISCHEMIA. CORONARY ARTERY BYPASS GRAFTING (CABG) WAS RECOMMENDED. THE PATIENT UNDERWENT CABG X3 INCLUDING LIMA TO LAD, REVERSE SVG TO DISTAL LCX, AND REVERSE SVG TO OM1. THE PATIENT WAS DISCHARGED TO A REHAB FACILITY ON ASPIRIN AND PRASUGREL.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE A DISSECTION OCCURRED. THE TARGET LESION WAS A BIFURCATED, 3.7MM, 90% STENOSED, 26MM LONG LESION LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX EXTENDING INTO THE DISTAL LEFT CIRCUMFLEX. THE PHYSICIAN TREATED THE LESION WITH DIRECT STENTING AND IMPLANTING A 3.5 X 28 TAXUS LIBERTE STENT PLACED JUST DISTAL TO THE TAKEOFF OF THE OBTUSE MARGINAL (OM). THE STENT WAS DEPLOYED AT 12 ATM AND REPEAT ANGIOGRAPHY WAS PERFORMED. THIS SHOWED EVIDENCE OF RESIDUAL DISEASE AT THE SITE OF THE TAKEOFF OF THE OM WITH A SLIGHT HAZINESS SUGGESTIVE OF THE POSSIBLE PRESENCE OF A DISSECTION IN THAT AREA. THE SITE CONFIRMED THAT THE TAXUS LIBERTE STENT CAUSED THE DISSECTION. THIS WAS TREATED BY IMPLANTING A 3.5X8MM TAXUS LIBERTE STENT PLACED IN AN OVERLAPPING FASHION WITH THE ORIGINAL STUDY STENT. RESIDUAL STENOSIS WAS 0%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS (R) LIBERTÉ (R) CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893728350 13345308

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention