BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2042542 · Received April 6, 2011

    Report

    Report Number
    2134265-2011-01210
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    February 11, 2011
    Report Date
    March 10, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT JAILING AND MYOCARDIAL INFARCTION OCCURRED. THE PATIENT PRESENTED DUE TO UNSTABLE ANGINA (BRAUNWALD CLASSIFICATION IIIC) AND UNDERWENT CARDIAC CATHETERIZATION WHICH REVEALED A 90% STENOSED AND 10MM LONG LESION IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD) WITH A REFERENCE VESSEL DIAMETER OF 2.5MM. THE LESION WAS TREATED WITH PREDILATION AND PLACEMENT OF A 2.75X16MM TAXUS LIBERTE STENT AND POST DILATION WHICH RESULTED IN 0% RESIDUAL STENOSIS. HOWEVER, STENT PLACEMENT RESULTED IN A SIDE BRANCH OCCLUSION. THE 1ST DIAGONAL VESSEL WITH A DIAMETER GREATER THAN OR EQUAL TO 2MM, WAS JAILED BY THE TAXUS LIBERTE STENT REDUCING THE FLOW IN THAT VESSEL TO TIMI-0. THE PATIENT EXPERIENCED ST ELEVATION AND NON Q-WAVE MYOCARDIAL INFARCTION. THE EVENT WAS TREATED WITH BALLOON ANGIOPLASTY WHICH RESULTED IN FULL RESTORATION OF FLOW. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND PRASUGREL.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS A BIFURCATED LESION. IT WAS ACCESSED WITH A 6F VL 3.5 GUIDE CATHETER AND A 0.014" 180CM NON-BSC GUIDE WIRE. PREDILATION WAS PERFORMED WITH A 2.5X12MM APEX BALLOON INFLATED TO 9ATM FOR 18 SECONDS. THE 2.75X16MM TAXUS LIBERTE STENT WAS DEPLOYED AT 9ATM FOR 14 SECONDS. THEN A 0.014" 190CM NON-BSC GUIDE WIRE WAS ATTEMPTED TO BE INSERTED INTO THE DIAGONAL BRANCH BUT IT WAS UNABLE CROSS. IT WAS EXCHANGED FOR A DIFFERENT 0.014 190CM NON-BSC GUIDE WIRE. A 1.5X12MM APEX BALLOON WAS ADVANCED BUT IT WAS UNABLE TO CROSS INTO THE DIAGONAL LESION. THE BALLOON AND WIRE WERE REMOVED AND A DIFFERENT 0.014" 190CM NON-BSC GUIDE WIRE WAS ADVANCED AND SUBSEQUENTLY REMOVED. IT WAS REPLACED WITH A 0.014" 185CM KINETIX GUIDE WIRE WHICH WAS SUCCESSFULLY ADVANCED INTO THE FIST DIAGONAL ARTERY. THEN A 2.0X12MM APEX BALLOON WAS ADVANCED AND INFLATED TO 10ATM FOR 21 SECONDS AND AGAIN TO 16ATM FOR 19 SECONDS. THEN A 2.75X15MM NON-COMPLIANT QUANTUM APEX WAS ADVANCED TO THE MID LAD AND INFLATED TO 12ATM FOR 27 SECONDS AND THEN MOVED TO THE FIRST DIAGONAL AND INFLATED TO 10ATM FOR 23 SECONDS AND THE PROCEDURE WAS CLOSED. 1 DAY POST PROCEDURE, THE PATIENT EXPERIENCED ELEVATED CARDIAC ENZYMES CONSISTENT WITH A MYOCARDIAL INFARCTION.

    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 H7493893616270 13605590

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention