BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1152463 · Received August 28, 2008

    Report

    Report Number
    2134265-2008-02473
    Event Type
    Injury
    Date Received
    August 28, 2008
    Date of Event
    March 7, 2008
    Report Date
    August 1, 2008
    Manufacturer
    BOSTON SCIENTIC
    Product Code
    NIQ
    PMA / PMN Number
    p030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; 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 PROD FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME CASE AS 2134265-2008-02474. IT WAS REPORTED, BY A MEDWATCH REPORT THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, A THROMBOSIS OCCURRED. THE LESION WAS PRE-DILATED WITH A 2.5 X 16 MM MAVERICK BALLOON. THE PHYSICIAN IMPLANTED 2 TAXUS EXPRESS2 DRUG ELUTING STENTS, A 3.0 X 20 MM AND A 2.5 X 24 MM. THE LESION WAS LOCATED IN THE 80% STENOSED PROXIMAL TO MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE MID LAD WAS STENTED WITH THE 2.5 X 24 MM TAXUS STENT AND THE PROXIMAL LAD WAS STENTED WITH THE 3.0 X 20 MM TAXUS STENT. THE STENTS WERE OVERLAPPING SLIGHTLY BOTH STENTS WERE POST DILATED WITH A 3.0 X 20 MM QUANTUM MAVERICK BALLOON. POST PROCEDURE, ON ARRIVAL IN THE CARDIAC SHORT STAY UNIT, THE PT COMPLAINED OF CHEST PAIN AND ST SEGMENT ELEVATIONS WERE NOTED. ANGIOGRAPHY REVEALED A THROMBOSIS IN THE LAD. AN EXPORT CATHETER AND ANGIOJET WERE USED TO PERFORM A THROMBECTOMY. THREE PASSES WERE PERFORMED. A 3.25 X 20 MM QUANTUM MAVERICK BALLOON WAS USED TO FURTHER DILATE BOTH STENTS. REPEAT ANGIOGRAPHY REVEALED EXCELLENT RESULTS WHITH BRISK DISTAL FLOW AND SOLVED ST ELEVATIONS. REOPRO WAS ADMINISTERED DURING THIS PROCEDURE. NO ADD'L PT INJURIES OR COMPLICATIONS WERE REPORTED.

    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 SCIENTIC 2.5 X 24 MM *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention