BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1652045 · Received April 6, 2010

    Report

    Report Number
    2134265-2010-01534
    Event Type
    Death
    Date Received
    April 6, 2010
    Date of Event
    October 12, 2009
    Report Date
    March 9, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    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 65% RESTENOSED 1.8X27MM TARGET LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. TREATMENT CONSISTED OF PRE DILATION WITH AN UNSPECIFIED 2.5X12MM BALLOON, THE PLACEMENT OF A 2.5X20MM TAXUS EXPRESS2 STUDY STENT AND POST DILATION WITH THE SAME 2.5X12MM PRE-DILATION BALLOON RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED 5 DAYS LATER ON BAYASPIRIN AND PLAVIX.NO ANGINA WAS CONFIRMED AT THE 6 & 9 MONTH FOLLOW UP VISITS. IN (B) (6) 2009, THE PATIENT WAS FOUND DEAD. THE CAUSE OF DEATH IS UNKNOWN. NO ADDITIONAL INFORMATION WAS AVAILABLE AND NO AUTOPSY WAS PERFORMED.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT PER THE PHYSICIAN, THE EVENT RELATION TO THE STUDY DEVICE WAS "UNKNOWN".

    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 H7493897020250 9650464

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death