BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1657548 · Received April 13, 2010

    Report

    Report Number
    2134265-2010-01791
    Event Type
    Death
    Date Received
    April 13, 2010
    Date of Event
    October 30, 2009
    Report Date
    March 15, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    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)

    Description of Event or Problem · 1

    (B) (4). IT WAS REPORTED THAT FOLLOWING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE PATIENT DIED. THE INDEX PROCEDURE TREATED THE DE NOVO, 75% STENOSED 2.5X10. 4MM TARGET LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. TREATMENT CONSISTED OF PRE DILATION WITH AN UNSPECIFIED 2.5X14MM BALLOON AND THE PLACEMENT OF A 2.5X16MM TAXUS EXPRESS2 DRUG STUDY STENT. IVUS WAS PERFORMED CONFIRMING THE STENT WAS WELL APPOSED RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED 2 DAYS LATER WITHOUT ANGINAL SYMPTOMS ON BAYASPIRIN AND PLAVIX. NO ANGINA WAS CONFIRMED AT THE 1 & 6 MONTH FOLLOW UP VISITS. IN (B) (6) 2009, A STUDY FOLLOW UP ANGIOGRAM CONFIRMED 0% STENOSIS OF THE TARGET LESION IN THE MID LAD AND THE PATIENT AGAIN HAD NO ANGINAL SYMPTOMS. IN (B) (6) 2009, THE PATIENT WAS HOSPITALIZED FOR MITRAL VALVE REPLACEMENT. IN (B) (6) 2009, THE PATIENT DEVELOPED A FEVER AND ENTERIC BACTERIUM WAS DETECTED IN THE BLOOD SERUM. ADMINISTRATION OF ANTIBIOTICS WAS STARTED. IN (B) (6) 2009, THE PATIENT DIED DUE TO SEPTIC SHOCK. NO AUTOPSY WAS PERFORMED. PER THE PHYSICIAN, THE EVENT WAS LISTED AS "NOT RELATED" TO THE STUDY STENT.

    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 - GALWAY H7493897016250

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death