BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS (R) LIBERTÉ (R)

    MDR report key: 1905781 · Received November 23, 2010

    Report

    Report Number
    2134265-2010-05236
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 28, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): 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)

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT POST PROCEDURE THE PATIENT EXPERIENCED CHEST PAIN SYNDROME. IN (B)(6) 2010, TARGET LESION 1 WAS LOCATED IN THE LEFT MAIN CORONARY ARTERY WITH 99% STENOSIS AND WAS 10MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.7MM. IT WAS TREATED WITH PREDILATATION AND A 2.75X16MM TAXUS LIBERTE STENT IMPLANTED. FOLLOWING POST DILATION RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND PRASUGREL. IN (B)(6) 2010, THE PATIENT EXPERIENCED CHEST PAIN SYNDROME. THE EVENT WAS RESOLVED WITHOUT RESIDUAL EFFECTS THE NEXT DAY. PER THE INVESTIGATOR THIS EVENT IS POSSIBLY RELATED TO THE STUDY DEVICE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE TREATMENT INCLUDED MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS (R) LIBERTÉ (R) CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893616270 13005635

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other