BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 3112351 · Received May 14, 2013

    Report

    Report Number
    2134265-2013-03199
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 16, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    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

    SAME PATIENT AS MDR# 2134265-2010-04816. SAME CASE AS MDR#2134265-2013-03198, 2134265-2013-03094, 2134265-2013-03582 AND 2134265-2013-03200. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, VESSEL DISSECTION AND CHEST PAIN OCCURRED. 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
    212930 ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE UNK692

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention