BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 3180632 · Received June 20, 2013

    Report

    Report Number
    2134265-2013-04450
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    April 18, 2013
    Report Date
    May 23, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    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)(6). DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR.: 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)(4). IT WAS REPORTED THAT SUBSEQUENT TO A CORONARY STENTING TREATMENT PROCEDURE THROMBOSIS OCCURRED. THE PATIENT WAS DIAGNOSED WITH STABLE ANGINA IN (B)(6) 2010 AND UNDERWENT A CARDIAC CATHETERIZATION PROCEDURE WHICH REVEALED 1 TARGET LESIONS. A 70% DE NOVO STENOSED LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH A REFERENCE VESSEL DIAMETER OF 3.75MM AND A LESION LENGTH OF 18MM. THE LESION WAS PREDILATED WITH AN UNSPECIFIED BALLOON AND 3.50X24MM TAXUS LIBERTE STENT WAS DEPLOYED, RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY ON ASPIRIN AND PRASUGREL. IN (B)(6) 2013 THE PATIENT RETURNED WITH SYMPTOMS OF PROGRESSIVE HEART FAILURE AND UNDERWENT CORONARY ANGIOGRAPHY WHICH REVEALED THROMBUS IN THE PROXIMAL LAD. AT THE TIME OF THE EVENT, THE PATIENT WAS TAKING ONLY ASPIRIN. THE PATIENT UNDERWENT 1-VESSEL CABG WITH REVERSE SAPHENOUS VEIN GRAFT TO LAD, MITRAL VALVE REPAIR (ANNULOPLASTY, VALVULOPLASTY), TRICUSPID VALVE REPAIR (DEVEGA REPAIR), AND LIGATION OF THE LEFT ATRIAL APPENDAGE. ELEVEN DAYS POST PROCEDURE THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND ON THE SAME DAY THE PATIENT WAS DISCHARGED ON ASPIRIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280495 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493893624350 12799882

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention