BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 2960660 · Received February 14, 2013

    Report

    Report Number
    2134265-2013-00560
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 13, 2013
    Report Date
    January 16, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6). DEVICE IS A COMBINATION PRODUCT. (B)(4). 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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    (B)(4) STUDY. SAME CASE AS MDR ID#: 2134265-2013-01094. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, IN-STENT RESTENOSIS AND INCOMPLETE STENT APPOSITION OCCURRED. IN (B)(6) 2012, THE PATIENT PRESENTED WITH STABLE ANGINA AND CARDIAC CATHETERIZATION WAS RECOMMENDED. THE TARGET LESION WITH PRE-EXISTING THROMBUS WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (MID LAD) WITH 70% STENOSIS AND WAS 20MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.50MM. THE PHYSICIAN TREATED THE LESION WITH DIRECT PLACEMENT OF A 2.75X32MM TAXUS LIBERTE STENT, WITH 0% RESIDUAL STENOSIS FOLLOWING POST-DILATION. A NON-TARGET LESION LOCATED IN THE DISTAL LAD WAS ALSO TREATED WITH PLACEMENT OF A 2.50X16MM PROMUS ELEMENT STENT. THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. IN (B)(6) 2013, THE PATIENT PRESENTED EMERGENTLY WITH COMPLAINTS OF RECURRENT, ACCELERATING CHEST PAIN AND EXTREME FATIGUE WITH MINIMUM EXERTION. AT THE TIME OF THE EVENT, THE PATIENT WAS TAKING ASPIRIN AND STUDY DRUG. NO ACTION WAS TAKEN REGARDING THE SAME. IT WAS NOTED THAT THE STUDY STENT WAS UNDER EXPANSION AND HAD 80% IN-STENT RESTENOSIS IN THE MID LAD EXTENDING TO THE PROXIMAL LAD. THIS WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF A 3.0X28MM PROMUS ELEMENT STENT. HOWEVER, POST DEPLOYMENT OF THIS STENT, SOME RESIDUAL DISEASE WAS NOTED TOWARDS THE PROXIMAL ORIGIN OF THE LAD, WHICH WAS TREATED WITH PLACEMENT OF A SECOND 3.00X20MM PROMUS ELEMENT STENT, WITH 10% RESIDUAL STENOSIS. IN ADDITION, A 75% STENOSED LESION BETWEEN THE TWO PREVIOUSLY PLACED STUDY STENTS IN THE MID LAD EXTENDING TO THE DISTAL LAD WAS TREATED WITH PLACEMENT OF A 2.75X18MM NON-BSC STENT, WITH 10% RESIDUAL STENOSIS. THE EVENT WAS CONSIDERED AS RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64168 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893632270 13769210

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R