BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1352114 · Received March 25, 2009

    Report

    Report Number
    2134265-2009-01165
    Event Type
    Death
    Date Received
    March 25, 2009
    Date of Event
    June 17, 2008
    Report Date
    March 3, 2009
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME CASE AS 2134265-2008-03011. IT WAS DISCOVERED ON FURTHER F/U THAT A SECOND STENT WAS IMPLANTED DURING THE INDEX PROCEDURE. IT WS FURTHER REPORTED THAT THE TARGET LESION WAS A 2.5MM, 90% STENOSED, 63MM LONG PORTION OF THE PROXIMAL LEFT ANTERIOR DESCENDING (PROX LAD) ARTERY. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATION AT 20 ATM. A 2.5X24MM TAXUS EXPRESS2 STENT WAS PLACED AT MAXIMUM PRESSURE OF 18 ATM. TWO NON BSC STENTS WERE ALSO PLACED IN THE TARGET LESION. RESIDUAL STENOSIS BECAME VISUALLY 0% DS (22% DS BY QCA ESTIMATE), AND GOOD STENT APPOSITION WAS CONFIRMED WITH IVUS. THERE WAS TIMI-3 FLOW. THE PT REMAINED IN HOSP FOR CHF CONTROL, BUT WAS DISCHARGED ON ASPIRIN AND PLAVIX. ONE HUNDRED AND TWENTY FIVE DAYS POST-INDEX PROCEDURE, THE PT DEVELOPED HEART FAILURE AND WAS ADMITTED. HEPACHRON, HEPARIN NA AND INOVAN WERE ADMINISTERED. THE HEART FAILURE WAS SUBSIDED AND THE PT WAS DISCHARGED 44 DAYS AFTER THE INDEX PROCEDURE. TWO HUNDRED AND NINE DAYS POST-INDEX PROCEDURE, THE PT DEVELOPED RESPIRATORY DISCOMFORT. PARACENTESIS OF THE PLEURAL CAVITY WAS PERFORMED, AND DOBUTAMINE, HEPARIN NA, CORETEC AND LASIX WERE ADMINISTERED, BUT THE PT EXPIRED 228 DAYS AFTER THE INDEX PROCEDURE. AN AUTOPSY WAS NOT PERFORMED. THE INVESTIGATOR REPORTED THAT THE CAUSALITY BETWEEN DEATH AND RESPIRATORY DISCOMFORT WAS UNK, AND THE CAUSALITY BETWEEN TARGET VESSEL AND RESPIRATORY DISCOMFORT WAS ALSO UNK. RESPIRATORY DISCOMFORT LED TO THE DEATH WAS JUDGED BY THE INVESTIGATOR TO BE UNK RELATIONSHIP TO THE TAXUS STENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM NIQ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC CORPORATION 3.00X28MM

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death PIXEL STENT| CYPHER STENT