BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2862932 · Received December 10, 2012

    Report

    Report Number
    2134265-2012-08061
    Event Type
    Death
    Date Received
    December 10, 2012
    Date of Event
    August 25, 2012
    Report Date
    November 8, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATED: PATIENT AGE AT TIME OF EVENT, PATIENT SEX, PATIENT IDENTIFIER AND PATIENT CODE. CORRECTION: DESCRIBE EVENT OR PROBLEM CORRECTED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE IS A 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. 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

    IT WAS FURTHER REPORTED THAT DURING THE INDEX PROCEDURE TWO LESIONS WERE TREATED. A NEW 90% STENOSED LESION AND THE OTHER WAS 99% IN-STENT RESTENOSIS. THE PATIENT WAS HOSPITALIZED AT AN OUTSIDE HOSPITAL AT THE TIME OF DEATH. NO RELEASE FORMS HAVE BEEN SIGNED AND RECORDS CAN NOT BE OBTAINED FROM THE OUTSIDE HOSPITAL.

    Description of Event or Problem · 1

    (B)(4) STUDY. SAME CASE AS MDR ID# 2134265-2012-08061. SAME PATIENT AS MDR ID# 2134265-2012-01781 AND 2134265-2012-01780. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, THE PATIENT EXPIRED. (B)(6) 2010 - THE PATIENT UNDERWENT THE INDEX PROCEDURE WITH THE DEPLOYMENT OF TWO DRUG-ELUTING STENTS (2.75X16MM AND 3.5X24MM) TAXUS LIBERTE STENTS TO THE SECOND OBTUSE MARGINAL BRANCH SEGMENT. POST PROCEDURAL RESIDUAL STENOSIS WAS 0% WITH TIMI 3 FLOW. (B)(6) 2012 - THE PATIENT PRESENTED WITH ISCHEMIC CARDIOMYOPATHY. THE PATIENT LATER EXPIRED. THE CAUSE OF DEATH WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THE PATIENT PRESENTED WITH ISCHEMIC CARDIOMYOPATHY AND THE CAUSE OF DEATH WAS UNKNOWN, HOWEVER, IT SHOULD HAVE STATED THAT THE PATIENTS' IMMEDIATE CAUSE OF DEATH WAS CARDIAC ARREST AND UNDERLYING CAUSES WERE ISCHEMIC CARDIOMYOPATHY AND SEVERE CORONARY ARTERY DISEASE.

    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 67 YR Death