BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1591500 · Received February 1, 2010

    Report

    Report Number
    2134265-2010-00621
    Event Type
    Injury
    Date Received
    February 1, 2010
    Date of Event
    December 28, 2009
    Report Date
    January 6, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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

    SAME CASE AS: 213425-2010-00622. IT WAS REPORTED THAT POST-CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE STENT THROMBOSIS OCCURRED. THE TARGET LESIONS WERE LOCATED IN THE RIGHT CORONARY ARTERY (RCA) MID CIRCUMFLEX (CX). DURING THE INDEX PROCEDURE, A TAXUS LIBERTE¿ 2.75X20MM STENT AND A TAXUS LIBERTE¿ 2.50X16MM STENT WERE IMPLANTED. LESS THAN TWO HOURS AFTER THE PROCEDURE, THE PATIENT EXPERIENCED ACUTE ST SEGMENT ELEVATION AND INFERIOR WALL INFARCTION. ACUTE STENT THROMBOSIS WAS FOUND IN THE RCA AND 90% STENOSIS AND VISIBLE THROMBUS IN THE CX. A NON-BSC ASPIRATION CATHETER WAS USED TO PERFORM THROMBECTOMY OF THE RCA. SIGNIFICANT IMPROVEMENT IN FLOW OCCURRED BUT THERE WAS STILL VISIBLE THROMBUS. A MAVERICK 3.0X20MM BALLOON WAS USED TO DILATE THE VESSEL TO 10-12 ATMS FOR 15-30 SECONDS. AFTER THIS, EXCELLENT ANGIOGRAPHIC RESULTS WERE VISIBLE WITH 0% RESIDUAL STENOSIS, NORMAL FLOW TO THE DISTAL VESSEL AND MARKED IMPROVEMENT IN ST SEGMENT ELEVATION. INTRAVASCULAR ULTRASOUND ALSO REVEALED ADEQUATE STENT EXPANSION AND APPOSITION OF THE VESSEL WALL. THROMBECTOMY WAS NOT POSSIBLE TO TREAT THE CX DUE TO SEVERE ANGULATION OF THE CX OF THE LEFT MAIN (LM). A MAVERICK 2.5X20MM BALLOON WAS USED TO PERFORM BALLOON ANGIOPLASTY THROUGHOUT THE MID CX. MULTIPLE INFLATIONS WERE PERFORMED TO 4-6 ATMS DISTALLY AND 14 ATMS PROXIMALLY. AFTER THIS, EXCELLENT ANGIOGRAPHIC RESULTS WERE OBSERVED WITH 5% RESIDUAL STENOSIS, NO VISIBLE THROMBUS AND NORMAL FLOW TO THE DISTAL VESSEL. BEYOND THE STENT SEGMENT, THERE WAS APPROXIMATELY 40-50% STENOSIS WHICH WAS UNCHANGED. MEDICATIONS ADMINISTERED DURING THE PROCEDURE INCLUDED REOPRO BOLUS AND HEPARIN INFUSION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND 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 H7493893620270 12153954

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention TAXUS LIBERTE'2.75X20MM