BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1781897 · Received August 3, 2010

    Report

    Report Number
    2134265-2010-03403
    Event Type
    Injury
    Date Received
    August 3, 2010
    Date of Event
    October 16, 2009
    Report Date
    July 9, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. IF IMPLANTED, GIVE DATE: 2009. DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA VOLUNTARY MEDWATCH (B)(4), THAT POST-DRUG ELUTING STENTING TREATMENT PROCEDURE, CHEST PAIN, ST ELEVATED MYOCARDIAL INFARCTION (STEMI) AND THROMBOSIS OCCURRED. PRIOR TO THE INDEX PROCEDURE, THE PATIENT PRESENTED WITH ACUTE CHEST SYNDROME (ACS). ANGIOGRAPHY REVEALED A DISCRETE 90% STENOSED LESION JUST DISTAL TO THE RIGHT POSTERIOR LATERAL (RPL) ARTERY AND A LONG 70% STENOSED LESION IN THE PROXIMAL TO MID RIGHT POSTERIOR DESCENDING (RPDA) ARTERY. A TAXUS LIBERTE 2.5X12MM STENT WAS DEPLOYED IN THE RIGHT RPL WITH 0% RESIDUAL STENOSIS WITH TIMI III FLOW. THEN THE RPDA WAS PRE-DILATED WITH AN APEX 2.5X15MM BALLOON. A TAXUS LIBERTE 3.0X32MM STENT WAS DEPLOYED AT THE LESION SITE AND RESIDUAL STENOSIS WAS 0% WITH TIMI II FLOW. THE PATIENT WAS TREATED WITH ASA, PLAVIX, AND HEPARIN AND THEN DISCHARGED. IN (B)(6) 2009, THE PATIENT PRESENTED WITH CHEST PAIN AND STEMI. ANGIOGRAPHY REVEALED COMPLETE OCCLUSION OF THE STENT IN THE RPL. THE STENT IN THE RPDA WAS WIDELY PATENT. AN APEX 2.5X15MM BALLOON WAS USED TO DILATE THE RPL. AFTER FOUR INFLATIONS WITH THE BALLOON, THERE WAS 20% RESIDUAL STENOSIS WITH TIMI III FLOW. THE PATIENT WAS TREATED WITH ASA, PRASUGREL AND HEPARIN. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493893612250 12703609

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 3.0X32MM TAXUS LIBERTE STENT| 2.5X15MM APEX BALLOON