BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 3112347 · Received May 14, 2013

    Report

    Report Number
    2134265-2013-03094
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    March 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLY 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 PATIENT AS MDR#2134265-2010-04816. SAME CASE AS MDR#2134265-2013-03198, 2134265-2013-03199, 2134265-2013-03582 AND 2134265-2013-03200. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, IN-STENT RESTENOSIS OCCURRED. IN (B)(6) 2009, THE PATIENT PRESENTED WITH UNSTABLE ANGINA (BRAUNWALD CLASS IB) AND WAS REFERRED FOR CARDIAC CATHETERIZATION. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 70% STENOSED, 12 X 2.5MM TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). THE TARGET LESION WAS TREATED WITH PRE-DILATATION USING A 2.5 X 12MM APEX BALLOON. THERE WAS RECOILING OF THE LESION AND A 3.0 X 20 MM STUDY STENT WAS DEPLOYED WITH 0% RESIDUAL STENOSIS. A NON-TARGET LESION IN THE RAMUS WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF A 2.5 X 12 MM TAXUS LIBERTE STENT WITH 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2010, THE PATIENT PRESENTED WITH UNSTABLE ANGINA AND UNDERWENT CORONARY ANGIOGRAPHY WHICH REVEALED 80% IN STENT RESTENOSIS OF THE PROXIMAL EDGE OF THE PREVIOUSLY PLACED STENT IN THE RAMUS. THE RESTENOSIS WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.5 X 15 MM PROMUS STENT. A 90% LESION IN THE LATE MID OF THE RCA AND 60-70% STENOSIS NOTED BEFORE THE RIGHT POSTERIOR DESCENDING ARTERY (R-PDA) WERE TREATED WITH PLACEMENT OF 2.5 X 23 MM PROMUS DRUG ELUTING STENT. IN (B)(6) 2013, THE PATIENT PRESENTED WITH CHEST DISCOMFORT AND NUCLEAR STRESS TEST REVEALED ABNORMAL FOR INFERIOR WALL REVERSIBLE ISCHEMIA CORRESPONDING TO WALL MOTION ABNORMALITIES. IN (B)(6) 2013, THE PATIENT WAS HOSPITALIZED. THE 85% IN-STENT RESTENOSIS OF THE PREVIOUSLY PLACED 2.5 X 15 MM PROMUS DRUG ELUTING STENT AND 60% MID STENOSIS OF THE PREVIOUSLY PLACED 2.5 X 12 MM TAXUS LIBERTE STENT NOTED IN THE NON-TARGET VESSEL RAMUS WERE TREATED WITH A 2.5 X 10MM FLEXTOME CUTTING BALLOON WHICH WAS UNABLE TO CROSS THE LESION. PRE-DILATATION WAS PERFORMED USING A 2.50 X 15MM APEX BALLOON. THE PATIENT COMPLAINED OF CHEST PAIN ON A SCALE OF 4. AFTER PLACEMENT OF A 2.5 X 24MM ION STENT, 2 MILLIGRAMS MORPHINE SULPHATE WERE ADMINISTERED. THE STENT WAS POST-DILATED USING THE SAME 2.5 X 15 MM APEX BALLOON AND STILL THE PATIENT COMPLAINED OF CHEST PAIN ON A SCALE OF 8. TWO MILLIGRAMS OF MORPHINE SULPHATE WERE ADMINISTERED. FOLLOWING STENT IMPLANTATION, THE ORIGIN OF THE RAMUS ARTERY WAS COMPROMISED AND A SMALL DISSECTION WAS NOTED. A 2.25 X 8 MM ION STENT WAS DEPLOYED AND REPEAT ANGIOGRAPHY REVEALED NO COMPROMISE AT THE LEFT ANTERIOR DESCENDING ARTERY (LAD) OR LEFT CIRCUMFLEX ARTERY (LCX) AND REVEALED NO DISSECTION. THERE WAS 0% RESIDUAL STENOSIS. TWO MORE MILLIGRAMS OF MORPHINE SULPHATE WERE ADMINISTERED AFTER WHICH THE PATIENT COMPLAINED OF CHEST PAIN ON A SCALE OF 1. THE NEXT DAY THE EVENT RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212810 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY UNK433

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R