BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1982894 · Received February 9, 2011

    Report

    Report Number
    2134265-2011-00303
    Event Type
    Injury
    Date Received
    February 9, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 18, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. PATIENT IDENTIFIER: (B)(6). DEVICE EVALUATED BY MFR. 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 MFR ID: 2134265-2011-00302, 2134265-2011-00296. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A VESSEL SPASM, THROMBUS EMBOLIZATION AND MYOCARDIAL INFARCTION OCCURRED. DUE TO A CLINICAL ASSESSMENT INCLUDING UNSTABLE ANGINA (BRAUNWALD CLASSIFICATION IB), THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION WHICH REVEALED A 90% STENOSED AND 2.75 X 20MM LESION WITH THROMBUS LOCATED IN THE SAPHENOUS VEIN GRAFT (SVG) TO THE FIRST OBTUSE MARGINAL (OM1) CORONARY ARTERY. A 6F GUIDE CATHETER WAS USED TO CANNULATE THE TARGET VESSEL. A CHOICE PT GUIDE WIRE WAS PLACED IN THE TARGET VESSEL. A NON BSC ASPIRATION CATHETER WAS USED TO REDUCE THE THROMBUS BURDEN. A 2.5X20MM APEX BALLOON WAS USED TO PREDILATE THE LESION. IT WAS THEN EXCHANGED FOR A 2.5X20MM TAXUS LIBERTE STENT WHICH WAS INFLATED TO 12 ATM RESULTING IN 0% RESIDUAL STENOSIS. HOWEVER, THE SITE REPORTS THAT FOLLOWING STENT DEPLOYMENT "THERE APPEARED TO BE SOME SPASM OR PERHAPS THROMBUS DISTALLY". IV NIPRIDE AND NITROGLYCERINE WAS ADMINISTERED WHICH PER THE SITE "DID NOT HELP MUCH AND I MAY HAVE LIFTED A PLAQUE WITH THE WIRE, OR MORE LIKELY PLAQUE/THROMBUS FROM THE LESION EMBOLIZED". THE PROXIMAL PORTION OF THE LESION LOOKED "A LITTLE WORSE". ATTEMPTS WERE MADE WITH MULTIPLE WIRES TO CROSS THE PREVIOUSLY PLACED STENT. THEN A 3.0X20MM QUANTUM APEX WAS ADVANCED AND THE STENT WAS POST DILATED UP TO 16 ATM. THEN A 2.75X30MM TAXUS LIBERTE WAS ADVANCED AND PLACED PROXIMALLY AND INFLATED UP TO 16 ATM RESULTING IN 0% RESIDUAL STENOSIS. TIMI-3 FLOW WAS CONFIRMED, THE PATIENT WAS PAIN FREE AND THE DISTAL LESION WAS BEGINNING TO "PLUMP UP", SO THE PROCEDURE WAS CLOSED. THE EVENTS OF VESSEL SPASM, THROMBUS AND PLAQUE SHIFT WERE REPORTED TO BE RESOLVED WITHOUT RESIDUAL EFFECTS. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED A PERI-PROCEDURAL MYOCARDIAL INFARCTION, WHICH WAS TREATED WITH MEDICAL THERAPY AND RESOLVED WITHOUT RESIDUAL EFFECTS. THE PATIENT WAS DISCHARGED 1 DAY LATER 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 H7493893620270 13528199

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention 3.0X20MM QUANTUM APEX BALLOON| PRONTO ASPIRATION CATHETER| 2.5X20MM TAXUS LIBERTE STENT| 2.5X20MM APEX BALLOON| CHOICE PT WIRE