BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 484934 · Received September 24, 2003

    Report

    Report Number
    6000089-2003-00720
    Event Type
    Death
    Date Received
    September 24, 2003
    Date of Event
    August 21, 2003
    Report Date
    August 28, 2003
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THREE DAYS FOLLOWING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE PATIENT DIED. THE PHYSICIAN IMPLANTED A TAXUS EXPRESS2 DRUG ELUTING STENT IN A 99% STENOTIC LEFT MAIN/OSTIAL LAD LESION. THERE WAS NOTHING UNUSUAL ABOUT THE PROCEDURE. THE STENT WAS EASILY DEPLOYED AND THE PROCEDURE WAS CONSIDERED SUCCESSFUL. THE PATIENT DID WELL, WITHOUT SPECIFIC COMPLAINTS UNTIL 3 DAYS LATER WHEN THEY DEVELOPED AN ABRUPT ONSET OF IRRITABLITY, LOSS OF COOPERATION AND SUDDENLY COLLAPSED. EKG DID NOT REVEAL S-T SEGMENT CHANGES OR Q WAVES. THEY DIED APPROXIMATELY 25 MINUTES AFTER THE ONSET OF SYMPTOMS. THE PHYSICIAN HAS INDICATED THAT HE IS UNCERTAIN OF THE CAUSE OF DEATH, OR IF THERE IS A RELATIONSHIP OF THE EVENT TO THE TAXUS STENT. HE CONSIDERED THIS A "DELICATE" INTERVENTIONAL PROCEDURE DUE TO THE 99% LEFT MAIN CORONARY ARTERY INVOLVEMENT. HE INDICATED THAT A POSSIBLE CAUSE OF DEATH IS A MASSIVE CEREBRAL HEMORRHAGE LEADING TO A STROKE AND SUBSEQUENT DEATH. AN AUTOPSY WILL NOT BE PERFOMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM DRUG COATED STENT NIQ BOSTON SCIENTIFIC TAXUS EXPRESS2 8.8% 3.00 X 16 MM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death