BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS (R) LIBERTÉ (R) LONG

    MDR report key: 2222057 · Received August 24, 2011

    Report

    Report Number
    2134265-2011-03665
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    July 22, 2011
    Report Date
    July 28, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6). DEVICE IS A COMBINATION PRODUCT DEVICE EVALUATED 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).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE CHEST PAIN AND SHORTNESS OF BREATH OCCURRED. THE TARGET LESION WAS LOCATED IN THE MID SAPHENOUS VEIN GRAFT (SVG) TO THE OBTUSE MARGINAL (OM) WITH 75% STENOSIS AND WAS 36.0 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4.0 MM. THE PHYSICIAN TREATED THE LESION WITH DIRECT STENT PLACEMENT USING A 4.00 X 38 MM TAXUS LIBERTE STENT WITH 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND PRASUGREL. AT 184 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED WITH CHEST PAIN AND SHORTNESS OF BREATH. THE NEXT DAY A CORONARY ANGIOGRAPHY REVEALED 75% IN-STENT RESTENOSIS IN THE SVG OF THE OM. THE PATIENT UNDERWENT A TARGET VESSEL REVASCULARIZATION OF THE TARGET LESION WITH STENT PLACEMENT AND 0% RESIDUAL STENOSIS. A NEW LESION IN THE RIGHT CORONARY ARTERY WAS ALSO TREATED WITH STENT PLACEMENT. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND PRASUGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS (R) LIBERTÉ (R) LONG CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893738400 13597934

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention