BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1962561 · Received January 18, 2011

    Report

    Report Number
    2134265-2010-05983
    Event Type
    Injury
    Date Received
    January 18, 2011
    Date of Event
    November 18, 2010
    Report Date
    December 20, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).DEVICE IS COMBINATION PRODUCT.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

    (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE STUDY STENT DID NOT FULLY EXPAND. THE INDEX PROCEDURE TREATED THE 80% STENOSED, 2.75X13MM TARGET LESION LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. TREATMENT CONSISTED OF PRE DILATION AND THE PLACEMENT OF A 2.75X28MM (B)(6) STUDY STENT. POST IVUS WAS PERFORMED REVEALING THE STENT WAS UNDER EXPANDED. TREATMENT CONSISTED OF ADDITIONAL POST DILATIONS WITH A NON-COMPLIANT BALLOON RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND PRASUGREL.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT A PERIPROCEDURAL MI OCCURRED ONE DAY POST THE INDEX PROCEDURE. NO ACTION WAS TAKEN AND THE EVENT RESOLVED WITHOUT RESIDUAL EFFECT.

    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 H7493893628270 13671403

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention