BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT

    MDR report key: 734170 · Received July 7, 2006

    Report

    Report Number
    6000089-2006-01406
    Event Type
    Death
    Date Received
    July 7, 2006
    Date of Event
    May 28, 2006
    Report Date
    June 15, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT. SHOULD FURTHER RELEVANT INFORMATION BECOME AVAILABLE; A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FIVE DAYS FOLLOWING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE PT EXPERIENCED THROMBOSIS AND DIED. VIA THE RIGHT FEMORAL ARTERY, THE PHYSICIAN USED THESE PRODUCTS FOR CARDIAC CATHETERIZATION: 1 INPUT INTRODUCER, PS 6F, 1 SCIMED GUIDE 0.35 X 145 CM, 1 JUDKINS CATHETER JL4 6F, 1 JUDKINS CATHETER JR4 6F, 1 XB GUIDE CATHETER 4.0 6F, 1 PTCA GUIDE PT 2 AND 2 WHISPER PTCA GUIDES 0.14" X 190 CM. THE TARGET LESION WAS LOCATED IN A 90% STENOSED SEGMENT OF THE MID ANTERIOR DESCENDING ARTERY. THE PHYSICIAN PREDILATED THE LESION USING A 2.5X20MM MAVERICK BALLOON. A 2.75 X 28MM AND 3.0X28MM TAXUS LIBERTE' DRUG ELUTING STENTS WERE PLACED. THERE WERE NO PT COMPLICATIONS. CLOPIDOGREL WAS ADMINISTERED FOLLOWING STENT IMPLANTATION. TWO DAYS LATER, A 90% STENOSED SEGMENT OF THE 2ND MARGINAL BRANCH WAS PREDILATED USING A 2.0X20MM MAVERICK BALLOON AND A 2.75X28MM TAXUS LIBERTE' STENT WAS PLACED. BALLOON DILATION USING A 2.5X20MM MERCURY BALLOON WAS PERFORMED IN BOTH THE MID CIRCUMFLEX ARTERY AND THE 2ND MARGINAL BRANCH. THERE WERE NO PT COMPLICATIONS. EIGHT DAYS FOLLOWING THE INITIAL PROCEDURE, IT WAS REPORTED THAT THE PT PRESENTED TO ANOTHER HOSP WITH CHEST PAIN AND SPENT A CRITICAL PERIOD WITH LOW BLOOD PRESSURE THROMBOSIS WAS FOUND IN THE LEFT CORONARY ARTERY AND THE PT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT DRUG COATED STENT NIQ BOSTON SCIENTIFIC 3.0 X 28MM 8217718

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death