BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 2821678 · Received November 6, 2012

    Report

    Report Number
    2134265-2012-06665
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 9, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. (B)(4). DEVICE EVALUATION 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED IN (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH NON Q-WAVE NON-ST SEGMENT ELEVATION MYOCARDIAL INFARCTION (NSTEMI). IN (B)(6) 2012, THE 99% STENOSIS THAT WAS NOTED IN THE MID RIGHT CORONARY ARTERY AND WAS TREATED WITH PLACEMENT OF A 3.50 X 12 MM PROMUS STENT, RESULTING IN 0% RESIDUAL STENOSIS.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED POST A STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED CHEST PAINS AND A MYOCARDIAL INFARCTION. IN (B)(6) 2010, THE PATIENT PRESENTED WITH UNSTABLE ANGINA AND CARDIAC CATHETERIZATION WAS RECOMMENDED. THE 80% STENOSED AND 8MM LONG TARGET LESION WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY WITH A REFERENCE VESSEL DIAMETER OF 3MM. THE TARGET LESION WAS TREATED WITH DIRECT STENT PLACEMENT OF A 12X2.25MM TAXUS LIBERTE ATOM STENT, RESULTING IN 0% RESIDUAL STENOSIS. IN (B)(6) 2012, THE PATIENT PRESENTED WITH CARDIAC CHEST PAINS AND WAS HOSPITALIZED THE SAME DAY. THE FOLLOWING DAY THE PATIENT WAS DIAGNOSED WITH ARC DEFINITION MYOCARDIAL INFARCTION, EVENT WAS CONSIDERED TO BE RESOLVED WITHOUT RESIDUAL EFFECTS. THE FOLLOWING DAY A 99% STENOSIS WAS NOTED IN THE MID RIGHT CORONARY ARTERY AND WAS TREATED WITH PLACEMENT OF AN UNKNOWN MANUFACTURER'S STENT, RESULTING IN 0% RESIDUAL STENOSIS. THE FOLLOWING DAY THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THE TARGET LESION WAS IN THE SAPHENOUS VEIN GRAFT TO DISTAL RIGHT CORONARY ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893628300 12832170

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention