BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT

    MDR report key: 724482 · Received June 8, 2006

    Report

    Report Number
    6000089-2006-01111
    Event Type
    Death
    Date Received
    June 8, 2006
    Date of Event
    May 1, 2006
    Report Date
    May 9, 2006
    Manufacturer
    BOSTON SCIENTTIFIC
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 9

    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 BECOMES AVAILABLE; A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 9

    IT WAS REPORTED THAT 16 HOURS FOLLOWING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE A THROMBOSIS OCCURRED AND THE PATIENT DIED. THE TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS, 90% STENOSED, 3.0MM DIAMETER SEGMENT OF THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD). A CORDIS INTRODUCER, A BMW GUIDEWIRE AND A CORDIS 7F JDL 3.5 GUIDING CATHETER WERE USED. THE LESION WAS PREDILATED USING A 25MM LENGTH BALLOON (UNKNOWN TYPE) INFLATED TO 14 ATMOSPHERES. A 20 X 3.0MM TAXUS LIBERTE' DRUG ELUTING STENT WAS DEPLOYED IN THE PROXIMAL LAD. THE OUTCOME WAS REPORTED AS SATISFACTORY. THIRTEEN HOURS LATER THE PATIENT EXPERIENCED CHEST PAIN, MYOCARDIAL INFARCTION, CARDIOGENIC SHOCK AND HYPOTENSION. ANGIOGRAPHY SHOWED THAT THE LAD WAS COMPLETELY OCCLUDED. THE PHYSICIAN TRIED TO RE-INTERVENE BY IMPLANTING TWO MEDTRONIC DRIVER BARE METAL STENTS, BUT THIS FAILED AND THE PATIENT DIED. IN THE OPINION OF THE PHYSICIAN THE THROMBOSIS WAS RELATED TO THE TAXUS LIBERTE' DRUG ELUTING STENT. THE PATIENT RECEIVED ASA, "MITROLATIVE", "MEPAVIN" AND A GENERIC IRANIAN BRAND OF PLAVIX. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO A MARKETED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT DRUG COATED STENT NIQ BOSTON SCIENTTIFIC 20 X 3.0MM 8207066

    Patients

    Seq Age Sex Outcome Treatment
    9 45 YR Death