BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STE

    MDR report key: 734344 · Received July 7, 2006

    Report

    Report Number
    6000089-2006-01407
    Event Type
    Injury
    Date Received
    July 7, 2006
    Date of Event
    May 30, 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 COMPLAINT 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 2 DAYS FOLLOWING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, THERE WAS THROMBOSIS. VIA THE LEFT FEMORAL ARTERY THE PHYSICIAN TREATED THE MID ANTERIOR DESCENDING, THE 2ND DIAGONAL BRANCH, THE 2ND MARGINAL BRANCH, AND THE CIRCUMFLEX (CX). THE FOLLOWING SUPPLIES WERE USED: 1 INPUT INTRODUCER. PS 2F, 1 SCIMED GUIDE 0.35 X 145 CM, 1 XB GUIDE CATHETER 3.5 7F, 2 PT2 PTCA GUIDES, 1 GRAPHIX PT PTCA GUIDE AND, 1 WHISPER PTCA GUIDE 0.14" X 190 CM. THE MID ANTERIOR DESCENDING WAS 80% STENOSED. THIS LESION WAS PREDILATED USING A A 2.0X14MM MERCURY BALLOON FOLLOWED BY PLACEMENT OF A 3.0X28MM TAXUS LIBERTE' DRUG ELUTING STENT. THE 2ND DIAGONAL BRANCH WAS 10% STENOSED; BALLOON DILATION WAS PERFORMED USING A 2.5X20MM MERCURY BALLOON. THE 2ND MARGINAL BRANCH WAS 50% STENOSED; BALLOON DILATION WAS PERFORMED USING A 2.0X14MM MERCURY BALLOON. THE CX WAS 50% STENOSED; BALLOON DILATION WAS PERFORMED IN THE MID CX USING A 2.5X20MM MERCURY BALLOON. THEN, 2 TAXUS LIBERTE' STENTS, SIZES 3.0X32MM, AND 3.0X16MM, WERE PLACED IN THE MID CX. A 3.X16MM TAXUS LIBERTE' STENT WAS PLACED IN THE PROXIMAL CX. THERE WERE NO PATIENT COMPLICATIONS. TWO DAYS AFTER THIS PROCEDURE THE PATIENT PRESENTED WITH STENT THROMBOSIS IN THE MID CX. EXTRACTION OF THE THROMBOTIC MATERIAL AND PLACEMENT OF A 3.5X32MM TAXUS LIBERTE' STENT WAS PERFORMED IN THE MID CX. THE PHYSICIAN ALSO TREATED THE 30% STENOSED COMMON TRUCK WITH PLACEMENT OF A 4.0X16MM TAXUS LIBERTE STENT. THERE WERE NO PATIENT COMPLICATIONS. PRODUCTS USED INCLUDED: 1 XB GUIDE CATHETER 3.5 6F, 1 INPUT INDTRODUCER, PS 6F, 1 PT2 PTCA GUIDE, AND 1 SCIMED GUIDE 0.35 X 260 CM. 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 STE DRUG COATED STENT NIQ BOSTON SCIENTIFIC 3 . 0 X 16 MM 8120812

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention