BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 3971753 · Received July 31, 2014

    Report

    Report Number
    2134265-2014-04455
    Event Type
    Death
    Date Received
    July 31, 2014
    Report Date
    July 8, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: 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)(4). SAME CASE AS MDR#2134265-2014-02429. IT WAS REPORTED THAT DEATH OCCURRED. ON AN UNKNOWN DATE, A TAXUS DRUG ELUTING STENT (DES) WAS IMPLANTED TO TREAT AN UNSPECIFIED LESION. IN 2005, THE PATIENT HAD ELECTIVE ANGIOPLASTY OF SAPHENOUS VEIN GRAFT (SVG) TO THE DIAGONAL BRANCH-TAXUS DES. THE PATENT HAD RECENTLY UNDERGONE CATHETERIZATION WHICH REVEALED SIGNIFICANT TRIPLE VESSEL CORONARY ARTERY DISEASE. IN 2008 THE PATIENT PRESENTED TO THE HOSPITAL WITH CARDIAC ARREST AND COMPLETE HEART BLOCK. CATHETERIZATION REVEALED 99% STENOSIS OF SVG TO DIAGONAL BRANCH. THE PATIENT. HAD PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY OF SVG TO DIAGONAL BRANCH PROXIMAL AND DISTAL STENOSES. A PACEMAKER WAS PLACED AS ARRHYTHMIA WAS BELIEVED TO BE THE CAUSE OF ARREST. TWO PROMUS STENTS WERE DEPLOYED, ONE IN THE DISTAL VEIN GRAFT AND ONE IN THE PROXIMAL GRAFT. IN (B)(6) 2010, THE 99% IN STENT RESTENOSIS OF THE PROMUS STENT IN THE DISTAL VEIN GRAFT WAS TREATED WITH PLACEMENT OF A 16 X 2.75MM TAXUS® LIBERTÉ® DRUG ELUTING. IN (B)(6) 2012, PATIENT HAD CATHETERIZATION DONE AND IT REVEALED: PATENT LEFT INTERNAL MAMMARY ARTERY (LIMA) TO LEFT ANTERIOR DESCENDING ARTERY (LAD), PATENT SAPHENOUS VEIN GRAFT (SVG) TO PD AND PATENT SVG TO DIAGONAL. THE PATIENT DIED AFTER TWENTY TWO DAYS. THE CAUSE OF DEATH WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448585 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY UNK433

    Patients

    Seq Age Sex Outcome Treatment
    1 Death