BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1950689 · Received January 6, 2011

    Report

    Report Number
    2134265-2010-05734
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    December 23, 2009
    Report Date
    December 7, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT IF IMPLANTED, GIVE DATE - 2009. DEVICE EVALUATED BY MANUFACTURER - THE COMPLAINANT 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

    DATE OF THIS REPORT - CORRECTED FROM (B)(6) 2010 TO (B)(6) 2010 ON INITIAL MFR REPORT# 2134265-2010-05734.

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT# 2134265-2010-05733, 2134265-2010-05735. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE; CHEST PAIN, ANGINA AND STENT "BLOCKAGE" OCCURRED. THE PATIENT PRESENTED WITH ANGINA. A TAXUS EXPRESS2 STENT OF UNKNOWN SIZE WAS PLACED IN THE LEFT CIRCUMFLEX ARTERY (LCX). THE PATIENT WAS PLACED ON PLAVIX. THREE MONTHS LATER THE PATIENT AGAIN WAS EXPERIENCING ANGINA AND A SECOND TAXUS EXPRESS2 STENT WAS PLACED IN A DE NOVO LESION IN THE LCX. THREE TO FOUR MONTHS AFTER THE SECOND PROCEDURE, THE PATIENT AGAIN WAS EXPERIENCING ANGINA A THIRD TAXUS EXPRESS2 STENT WAS PLACED IN ANOTHER DE NOVO LESION IN THE LCX. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PRIOR PLACED STENTS WERE NOTED TO BE PATENT DURING THE REINTERVENTIONS. APPROXIMATELY 3 MONTHS AFTER THE LAST STENT PLACEMENT IN (B)(6) OF 2009, THE PATIENT PRESENTED WITH ANGINA AND CHEST PAIN AND ALL THREE STENTS WERE "BLOCKED." CABG WAS PERFORMED WITH BYPASSES TO BOTH THE LEFT ANTERIOR DESCENDING ARTERY AND RIGHT CORONARY ARTERY. THE PATIENT WAS DISCHARGED AFTER 21 DAYS IN THE HOSPITAL. ONE YEAR LATER IN (B)(6) OF 2010, THE PATIENT PRESENTED WITH CHEST PAIN AND ANGINA. THE PATIENT IS BEING MEDICALLY MANAGED AND HAS BEEN PLACED IN AN OUTPATIENT ANGINA THERAPY PROGRAM. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IS NOT AVAILABLE.

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT# 2134265-2010-05733, 2134265-2010-05735. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE; CHEST PAIN, ANGINA AND STENT "BLOCKAGE" OCCURRED. THE PATIENT PRESENTED WITH ANGINA. A TAXUS EXPRESS2 STENT OF UNKNOWN SIZE WAS PLACED IN THE LEFT CIRCUMFLEX ARTERY (LCX). THE PATIENT WAS PLACED ON PLAVIX. THREE MONTHS LATER THE PATIENT AGAIN WAS EXPERIENCING ANGINA AND A SECOND TAXUS EXPRESS2 STENT WAS PLACED IN A DE NOVO LESION IN THE LCX. THREE TO FOUR MONTHS AFTER THE SECOND PROCEDURE, THE PATIENT AGAIN WAS EXPERIENCING ANGINA A THIRD TAXUS EXPRESS2 STENT WAS PLACED IN ANOTHER DE NOVO LESION IN THE LCX. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PRIOR PLACED STENTS WERE NOTED TO BE PATENT DURING THE REINTERVENTIONS. APPROXIMATELY 3 MONTHS AFTER THE LAST STENT PLACEMENT IN (B)(6) 2009, THE PATIENT PRESENTED WITH ANGINA AND CHEST PAIN AND ALL THREE STENTS WERE "BLOCKED." CABG WAS PERFORMED WITH BYPASSES TO BOTH THE LEFT ANTERIOR DESCENDING ARTERY AND RIGHT CORONARY ARTERY. THE PATIENT WAS DISCHARGED AFTER (B)(6) IN THE HOSPITAL. ONE YEAR LATER IN (B)(6) 2010 THE PATIENT PRESENTED WITH CHEST PAIN AND ANGINA. THE PATIENT IS BEING MEDICALLY MANAGED AND HAS BEEN PLACED IN AN OUTPATIENT ANGINA THERAPY PROGRAM. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE UNK432

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention