BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1812654 · Received August 24, 2010

    Report

    Report Number
    2134265-2010-03672
    Event Type
    Injury
    Date Received
    August 24, 2010
    Date of Event
    June 20, 2010
    Report Date
    July 27, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM UPDATED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4)

    Description of Event or Problem · 1

    SAME PATIENT AS: 2134265-2010-03673, 2134265-2010-03599, 2134265-2010-03674, 2134265-2010-03675. IT WAS REPORTED THAT POST A DRUG ELUTING STENTING TREATMENT PROCEDURE, PATIENT COMPLICATIONS OCCURRED. IN (B)(6) 2010, THE PATIENT HAD TWO UNSPECIFIED TAXUS STENTS IMPLANTED AND THREE DAYS LATER HAD THREE MORE UNSPECIFIED TAXUS STENTS IMPLANTED. SINCE THE PROCEDURES THE PATIENT HAS EXPERIENCED SHORTNESS OF BREATH, CHEST PAIN AND FEVER. IN ADDITION THE PATIENT WAS HOSPITALIZED FOR 8 DAYS AFTER THE PROCEDURES, PLATELET COUNTS ARE 'DOWN TO 84' AND A CT SCAN REVEALED MULTIPLE PULMONARY EMBOLI. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS DETERMINED THAT THIS IS A DUPLICATE TO MFR#: 2134265-2010-03388.

    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 - MAPLE GROVE UNK433

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| O