BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 959297 · Received December 5, 2007

    Report

    Report Number
    6000093-2007-02281
    Event Type
    Injury
    Date Received
    December 5, 2007
    Date of Event
    October 28, 2007
    Report Date
    November 7, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, A STENT DISLODGMENT OCCURRED. THE PT WAS ADMITTED TO THE HOSPITAL WITH SEVERE LEFT ANTERIOR CHEST PAIN THAT HAD LASTED FOR 3 HOURS. AN EKG SHOWED TRANSIENT T WAVE INVERSION IN THE INFERIOR LEADS AND THERE WAS A SLIGHT BUMP IN THE TROPONIN LEVELS. THE PHYSICIAN WAS UNABLE TO FEEL EITHER FEMORAL ARTERY PULSATIONS EVEN WITH THE USE OF THE SMART DOPPLER NEEDLE, THEREFORE, THE PROCEDURE WAS DONE THROUGH THE BRACHIAL ARTERY. THE TARGET LESION WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA) AND POSTERIOR LATERAL BRANCH (PLB). THE PROXIMAL AREA WAS WIRED EASILY; HOWEVER, THE PHYSICIAN WAS UNABLE TO CROSS THE DISTAL PLB LESION. THE WIRE WAS EXCHANGED. AS THE PROXIMAL AREA WAS CROSSED, THE PT EXPERIENCED ST SEGMENT ELEVATION WITH TIMI 1-2 FLOW, MOST LIKELY RELATED TO DISTAL EMBOLIZATION. ANOTHER MFR'S 4.0 X 23MM STENT WAS PLACED, HOWEVER. THERE WAS SLOW FLOW DISTALLY. VERAPAMIL AND NTG WERE INJECTED AND THE PHYSICIAN WAS ABLE TO WIRE THE PLB. MULTIPLE OVERLAPPING INFLATIONS WITH A 2.0 X 12MM BALLOON OBTAINED EXCELLENT RESULTS. THE PHYSICIAN "DEBATED" WHETHER ANOTHER STENT SHOULD BE PLACED AS HE DID NOT WANT TO COMPROMISE THE BIFURCATION TO THE PLB AND PDA. THE PHYSICIAN TRIED TO ADVANCE THE TAXUS EXPRESS2 2.5 X 20MM DRUG ELUTING STENT, BUT WAS UNABLE TO ADVANCE IT DISTALLY. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE DEVICE INTO THE GUIDE CATHETER BUT WAS UNABLE TO BECAUSE OF A KINK. THEREFORE, THE GUIDE CATHETER, WIRE AND THE STENT DELIVERY SYSTEM WERE PULLED OUT AS A UNIT. HOWEVER, THE STENT SHEARED OFF THE BALLOON AT THE TIP OF THE SHEATH. THE PT WAS STABLE AND ST ELEVATIONS HAD RESOLVED, THEREFORE, THE PHYSICIAN DECIDED TO ACCEPT THE ANGIOPLASTY RESULTS OF THE DISTAL VESSEL. THE VESSEL HAD TIMI 3 FLOW. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE WIRE THROUGH THE DISLODGED STENT, BUT WAS UNABLE TO. FINALLY, HE WAS ABLE TO REMOVE THE DISLODGED STENT WITH A GOOSE SNARE WIRE. NO FURTHER PT COMPLICATIONS OCCURRED. PT STATUS IS SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM NIQ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC CORP. 2.5X20MM 9296906

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention 4.0X23MM VISION STENT