BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2103379 · Received May 26, 2011

    Report

    Report Number
    2134265-2011-02024
    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
    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. DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    (B)(4). SAME CASE AS 2134265-2011-02023; 2134265-2011-02027 AND 2134265-2011-02028. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY TREATMENT PROCEDURE THE PATIENT EXPERIENCED RESTENOSIS. 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 H7493893612270 13356957

    Patients

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