BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT

    MDR report key: 702258 · Received April 17, 2006

    Report

    Report Number
    6000089-2006-00630
    Event Type
    Death
    Date Received
    April 17, 2006
    Date of Event
    January 24, 2006
    Report Date
    March 14, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    SAME CASE AS MFR #'S: 6000089-2006-00628, 6000089-2006-00631, 6000089-2006-00632. 40 DAYS AFTER A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE PATIENT EXPIRED. THE INDEX PROCEDURE IDENTIFIED FOUR TARGET LESIONS TREATED WITH TEN STENTS. THE FIRST TARGET LESION WAS A TRIFURCATED LESION OF THE LEFT MAIN, THE PROXIMAL CIRCUMFLEX AND THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERIES. THIES WAS A TYPE C BIFURCATED LESION. THE LESION WAS NOT PRE-DILATED. THE PHYSICIAN PLACED THREE TAXUS EXPRESS2 STENTS, A 3.00 X 12MM, AND TWO 2.75 X 16MM, USING THE CLASSIC T-STENTING, SIDE BRANCH FIRST TECHNIQUE. THE STENTS WERE NOT POST DILATED. AFTER STENT PLACEMENT, THERE WAS LESS THAN 30% RESIDUAL STENOSIS IN ALL THREE TAXUS EXPRESS2 STENTS AND THERE WAS TIMI-3 FLOW. THERE WERE TOW ADDITIONAL UNKNOWN TYPE AND SIZE STENTS PLACED IN THIS LESION. THE SECOND TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY. THE PHYSICIAN DIRECT-STENTED THE LESION WITH A TAXUS EXPRESS2 2.75 X 12MM STENT. THE STENT WAS NOT POST DILATED. POST DEPLOYMENT, THERE WAS LESS THAN 30% RESIDUAL STENOSIS AND TIMI-3 FLOW IN THIS LESION. THE PHYSICIAN ALSO PLACED ONE TSUNAMI STENT AND AN ADDITIONAL THREE UNKNOWN TYPE STENTS IN THE PROXIMAL AND MID RCA VESSEL. THE PATIENT WAS DISCHARGED 5 DAYS LATER ON BETA BLOCKERS, ANGIOTENSIN II RECEPTOR ANTAGONISTS, ACETYLSALICYLIC ACID, THIENOPYRIDINE ANTIPLATELET, STATINS, DIURETICS, AND AMIDODARONE. THE PATIENT WAS ADMITTED TO ANOTHER HOSPITAL 33 DAYS FOLLOWING THE INDEX PROCEDURE DUE TO LUNG EDEMA AND LEFT VENTRICULAR FAILURE. THERE WERE NO LABORATORY/ECG SIGNS OF MYOCARDIAL ISCHEMIA/INFARCTION. THE PATIENT WAS INTUBATED BECAUSE OF GLOBAL RESPIRATORY INSUFFIECIENCY AND DEVELOPED PNEUMONIA/SEPTICEMIA/ACUTE NEPHRIC FAILURE THEREAFTER. THE PATIENT DIED OF MULTISYSTEM ORGAN FAILURE 40 DAYS FOLLOWING THE INDEX PROCEDURE. THE RELATIONSHIP TO THE DEVICE IS INDICATED AS BEING POSSIBLY RELATED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC CORP. 2.75 X 16MM 7842109

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death