BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 578814 · Received March 4, 2005

    Report

    Report Number
    6000089-2005-00297
    Event Type
    Injury
    Date Received
    March 4, 2005
    Date of Event
    February 2, 2005
    Report Date
    February 2, 2005
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SAME AS MANUFACTURE# 6000089-2005-00296, 6000089-2005-00298, 6000089-2005-00299, 6000089-2005-00300. DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, NO RE-FLOW OCCURRED IN THE RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN PREDILATED THE LESION LOCATED IN THE RCA WITH A 2.0 X 15 MM MAVERICK BALLOON. AFTER PREDILATION THE PHYSICIAN SUCCESSFULLY DEPLOYED 5 TAXUS LIBERTE - 2.5 X 24, 2.75 X 24, 3.0 X 28, 3.0 X 12 AND 3.0 X 8 MM DRUG ELUTING STENTS. HOWEVER, WHEN STENTING THE RCA THERE WAS NO RE-FLOW NOTICED. THE PHYSICIAN TREATED THE NO RE-FLOW MEDICALLY WITH VERAPAMIL, GLYCERYL TRINITRATE (GNT), AND 2B3A INHIBITORS. IT IS NOTED THAT THE PHYSICIAN IS NOT KEEN IN REPORTING THIS CASE DOES NOT WANT TO BE CONTACTED. PT CURRENTLY HAD AN INFARCT AND A RUPTURED PAPILLARY MUSCLE WHICH REQUIRES REPLACEMENT OF THE VALVE. PT IS STILL IN THE INTENSIVE CARE UNIT. PT STATUS IS REPORTED AS "SATISFACTORY/GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM DRUG COATED STENT NIQ BOSTON SCIENTIFIC TAXUS LIBERTE - 2.75 X 24MM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention