BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 3090709 · Received May 2, 2013

    Report

    Report Number
    2134265-2013-03478
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    March 25, 2013
    Report Date
    April 4, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 AFTER A STENTING TREATMENT PROCEDURE A RESTENOSIS OCCURRED. THE PATIENT UNDERWENT A CARDIAC CATHETERIZATION IN (B)(6) 2011. TARGET LESION ONE WAS A <= 99% STENOSED DE-NOVO LESION LOCATED IN THE DISTAL LEFT CIRCUMFLEX (LCX) WITH A REFERENCE VESSEL DIAMETER OF 3.00MM AND A LESION LENGTH OF 8.00MM. THE LESION WAS TREATED WITH 3.00X12MM 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 SUBJECT PRESENTED WITH LEFT CHEST PAIN RADIATING DOWN THE UPPER ARM TO THE WRIST. THE SUBJECT WAS DIAGNOSED WITH UNSTABLE ANGINA AND WAS HOSPITALIZED ON SAME DAY. CARDIAC CATHETERIZATION WAS RECOMMENDED. A <=99% DE-NOVO LESION WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF A NON-BSC DRUG ELUTING STENT, RESULTING IN 0% RESIDUAL STENOSIS. AT THE SAME DAY RIGHT CORONARY ANGIOGRAPHY WAS PERFORMED. A 6 F GUIDE CATHETER FR 4-SH AND A 18 CM LUGE GUIDEWIRE WAS PLACED IN THE DISTAL RIGHT CORONARY ARTERY. THE SUBJECT EXPERIENCED CHEST PAIN AT A SCALE OF 6 OUT OF 10 AND WAS TREATED WITH NITROGLYCERIN. IN ADDITION, A NON-TVR WAS PERFORMED AND 90% STENOSED LESION LOCATED IN THE DISTAL RIGHT CORONARY ARTERY WAS TREATED WITH A NON-BSC DRUG ELUTING STENT, RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY ON ASPIRIN AND PRASUGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191178 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493893612300 13696632

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention