BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2103376 · Received May 26, 2011

    Report

    Report Number
    2134265-2011-02027
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 28, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6). DEVICE IS A COMBINATION PRODUCT. (B)(4). 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). SAME CASE AS 2134265-2011-02024; 2134265-2011-02023 AND 2134265-2011-02028. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY TREATMENT PROCEDURE, THE PATIENT EXPERIENCED PLAQUE SHIFT AND STENT UNDER EXPANSION. THE TARGET LESION WAS A LONG LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY AND THE MID LAD WITH 85% STENOSIS AND WAS 12 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75 MM. THE PHYSICIAN TREATED THE LESION WITH DIRECT STENT PLACEMENT USING 2.75 X 12 MM AND 2.75 X 20 MM TAXUS LIBERTE STENTS. AFTER PLACEMENT OF THE 2.75 X 20 MM TAXUS LIBERTE STENT, THERE WAS NOTED JAILING OF THE OSTIUM OF THE 1ST DIAGONAL VESSEL. THIS WAS TREATED BY PASSING A NON BSC WIRE THROUGH THE STRUTS OF THE STENT AND THEN WITH INFLATIONS OF A 2.0 X 12 MM MAVERICK BALLOON WHICH RESTORED BRISK FLOW WITH 30% RESIDUAL STENOSIS. POST-DILATION WAS PERFORMED WITH 0% RESIDUAL STENOSIS. DURING THIS PROCEDURE, BEFORE TREATING THE LAD, THE 1ST DIAGONAL VESSEL WAS TREATED WITH BALLOON ANGIOPLASTY WITH 30% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED THE SAME DAY ON ASPIRIN AND PRASUGREL. AT 163 DAYS POST INDEX PROCEDURE, THE PATIENT UNDERWENT CARDIAC CATHETERIZATION DUE TO IN-STENT RESTENOSIS OF THE TAXUS LIBERTE STENTS. THE LAD IN-STENT RE-STENOSIS WAS TREATED WITH BALLOON ANGIOPLASTY. SUBSEQUENTLY, THE PROXIMAL LAD WAS TREATED WITH A 2.5 X 10 MM BSC CUTTING BALLOON AND PLACEMENT OF A 2.75 X 16 MM TAXUS LIBERTE STENT. AFTER INITIAL STENT DEPLOYMENT IVUS REVEALED UNDEREXPANSION OF THE 2.75 X 16 MM TAXUS LIBERTE STENT WHICH WAS TREATED WITH ADDITIONAL HIGH PRESSURE INFLATIONS OF A 3 MM QUANTUM APEX BALLOON WITH GOOD ANGIOGRAPHIC RESULTS. AFTER TREATMENT OF THE LAD, THE LEFT CIRCUMFLEX WAS TREATED WITH A 4.0 X 12 MM TAXUS LIBERTE STENT. AFTER DEPLOYMENT, IT WAS DETERMINED THAT A LARGER BALLOON WOULD BE NEEDED TO GET FULL EXPANSION OF THE STENT AND A 4.5 MM QUANTUM APEX BALLOON WAS INFLATED RESULTING IN 0% RESIDUAL STENOSIS. AFTER PLACEMENT OF THE STENT, BUT BEFORE ADDITIONAL BALLOON DILATION, THERE WAS A PLAQUE SHIFT INTO THE ORIGIN OF THE 1ST MARGINAL BRANCH WHICH WAS TREATED WITH A NON BSC WIRE THROUGH THE STRUTS OF THE 4.0 X 12 MM TAXUS LIBERTE STENT AND INFLATIONS OF A 2.5 X 8 MM MAVERICK BALLOON WITH EXCELLENT ANGIOGRAPHIC RESULTS. THE PATIENT WAS DISCHARGED THE SAME DAY ON ASPIRIN AND PRASUGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE UNK433

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention 2.75X20MM TAXUS LIBERTE STENT| 2.75X16MM TAXUS LIBERTE STENT| 2.75X12MM TAXUS LIBERTE STENT