BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS (R) LIBERTÉ (R)

    MDR report key: 1905459 · Received November 23, 2010

    Report

    Report Number
    2134265-2010-05382
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    April 19, 2010
    Report Date
    October 26, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE STUDY STENT HAD GOOD APPOSITION WHEN THE STENT WAS IMPLANTED IN (B)(6) 2009. THE STENT FRACTURED FOUND IN (B)(6) 2010 HAD MIGRATED TO THE AORTA. ONLY PART OF THE STENT HAD FRACTURED. THE PATIENT HAD NO SYMPTOMS DUE TO THIS EVENT. IT IS BELIEVED THAT DUE TO THE LESION BEING ACTIVELY WORKED ON, THE CAUSE OF THE STENT FRACTURE AND MIGRATION WAS CAUSED BY THE LESION CONDITIONS.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE FRACTURED STENT MIGRATED TO THE AORTA. CORRECTED INFORMATION STATES THAT PART OF THE STENT FRACTURED. THE PROXIMAL PORTION OF THE FRACTURED STENT EXTENDED BACK INTO THE AORTA.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE INDEX LESION WITH A REFERENCE VESSEL DIAMETER OF 3.50MM AND A LENGTH OF 8.0MM IN THE PROXIMAL RIGHT CORONARY ARTERY WAS VISUALLY 90% STENOSED. IT WAS TREATED WITH PLACEMENT OF A 3.50X12MM TAXUS LIBERTE STENT AND POST DILATATION. PRE-DILATATION WAS NOT PERFORMED. RESIDUAL STENOSIS BECAME VISUALLY 0% AND TIMI 3 FLOW HAD BEEN KEPT THROUGH THE PROCEDURE. THE PATIENT WAS DISCHARGED WITHOUT COMPLICATIONS THE NEXT DAY ON ASPIRIN AND CLOPIDOGREL BISULFATE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE ADVERSE EVENT HAS BEEN CORRECTED TO SILENT ISCHEMIA. THE EVENT WAS RESLOVED IN (B)(6) 2010.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, RESTENOSIS OCCURRED AND STENT DAMAGE WAS NOTED. THE PATIENT HAD AN UNKNOWN SIZE TAXUS LIBERTE STENT IMPLANTED IN THE PROXIMAL RIGHT CORONARY ARTERY ON AN UNKNOWN DATE. IN MAY 2010 CORONARY ANGIOGRAPHY FOUND THAT THE INFERIOR SEPTAL BRANCH WAS 90% STENOSED AND IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY THERE WAS 50% STENOSIS. THE TARGET LESION WHICH WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY WAS 75% RESTENOSED WITH A VESSEL DIAMETER OF 3.50MM. IN THE OPINION OF THE PHYSICIAN THIS EVENT WAS POSSIBLY RELATED TO THE TAXUS STENT AND UNRELATED TO THE ANTIPLATELETS. IT WAS ALSO FOUND THAT THE STUDY STENT HAD PROTRUDED FROM THE OSTIUM OF THE RIGHT CORONARY ARTERY AND PART OF THE STENT WAS FRACTURED. THE LESION WAS DILATED WITH AN UNKNOWN BALLOON CATHETER. THE RESTENOSIS WAS TREATED IN JUNE 2010 WITH CORONARY ARTERY BYPASS GRAFTING AND THE FRACTURED PORTION OF THE STENT WAS REMOVED DURING SURGERY. PATIENT'S OUTCOME IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS (R) LIBERTÉ (R) CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493893612350

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention