BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL- ELUTING CORONARY STENT SYSTEM

    MDR report key: 1080883 · Received July 23, 2008

    Report

    Report Number
    2134265-2008-02061
    Event Type
    Death
    Date Received
    July 23, 2008
    Date of Event
    November 20, 2005
    Report Date
    July 14, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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: 2134265-2008-02058, 2134265-2008-02059, 2134265-2008-02060, 2134265-2008-02062, 2134265-2008-02062, 2134265-2008-02063. IT WAS REPORTED THAT POST CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, A STENT THROMBOSIS OCCURRED. THE LESION WAS NOT PREDILATED. A 2.50X16MM TAXUS EXPRESS2 DRUG ELUTING STENT WAS DEPLOYED AT HIGH PRESSURES IN THE 80-90% STENOSED LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.50X12MM TAXUS EXPRESS2 DRUG ELUTING STENT WAS DEPLOYED IN THE MID CIRCUMFLEX (CX) AND 2.50X20MM TAXUS EXPRESS2 DRUG ELUTING STENT WAS DEPLOYED AT MODERATELY HIGH PRESSURES IN THE TYPE C STENOSED PROXIMAL CIRCUMFLEX (CX). THE PROCEDURE WAS CARRIED OUT WITH SOME DIFFICULTY DUE TO THE SEVERITY OF THE STENOTIC LESIONS OF THE LAD AND THE MID CX, SINCE THERE WAS NO PREDILITATION. THE STENOSIS WAS REDUCED TO 0% IN THE STENTED LESIONS. MEDICATIONS: HEPARIN AND INTEGRILIN. THE PT TOLERATED THE PROCEDURE AND WAS RETURNED TO HIS ROOM ASYMPTOMATIC AND IN GOOD GENERAL CONDITION. TWENTY DAYS LATER, THE PT RETURNED FOR STENTING IN THE RIGHT CORONARY ARTERY (RCA). THE LESION WAS PREDILATED WITH A 2.5X10MM NON-BSC BALLOON. THE PHYSICIAN DEPLOYED A 2.50X16MM TAXUS EXPRESS 2 DRUG ELUTING STENT IN THE 80-90% STENOSED DISTAL RCA, INFLATED TO 12ATM. A 2.50X20MM TAXUS EXPRESS2 DRUG ELUTING STENT IN THE 60% STENOSED PROXIMAL RCA. A 2.50X8MM TAXUS EXPRESS 2 DRUG ELUTING STENT WAS DEPLOYED IN THE RCA, DUE TO A SMALL PORTION OF THE OSTIUM BEING STENOSED. THE STENOSIS WAS REDUCED TO 0% IN THE STENTED LESIONS. MEDICATIONS: HEPARIN AND INTEGRILIN. THE PT TOLERATED THE PROCEDURE AND WAS RETURNED TO HIS ROOM ASYMPTOMATIC AND IN GOOD CONDITION. ONE YEAR AND THREE MOS POST THE INITIAL STENTING PROCEDURE, THE PT COLLAPSED IN THE FOREST, WITHOUT SYMPTOMS OF ANGINA. THE PTS PLAVIX HAD BEEN DISCONTINUED ABOUT ONE MONTH PRIOR TO THE EVENT. THE PT WAS RESUSCITATED BY EMERGENCY MEDICAL SERVICE PERSONNEL. THE PT WAS TAKEN TO THE ER, WHERE HE HAD A PROLONGED ARREST WITH RESUSCITATION. THE PT EXPERIENCED: ELECTRO-MECHANICAL DISSOCIATION (EMD), VENTRICULAR FIBRILLATION, ASYSTOLE, AND VENTRICULAR TACHYCARDIA (VT). AFTER BEING INTUBATED AND GIVEN HEPARIN, AMIODARONE, AND DOPAMINE, THE PT WAS TRANSFERRED TO ANOTHER FACILITY VIA HELICOPTER. THE PT ARRESTED DURING TRANSPORT AND WAS RESUSCITATED USING EPINEPHRINE. WHEN THE PT ARRIVED AT THE HOSPITAL, HE WAS UNRESPONSIVE, BUT HAD A FEMORAL PULSE AND ERRATIC HEART RHYTHM. THE PT WAS BROUGHT TO THE CATH LAB. AN INTRAAORTIC BALLOON PUMP WAS PLACED. THE PT WAS PLACED ON AN EPINEPHRINE DRIP. AMIODARONE WAS GIVEN FOR VT. ANGIOGRAPHY IDENTIFIED THE LAD WAS FUNCTIONALLY OCCLUDED WITH TIMI 1 FLOW PROXIMALLY AND THE RCA WAS TOTALLY OCCLUDED WITH EVIDENCE OF A CLOT. MULTIPLE DILATATIONS WERE MADE IN THE LAD WITH A 3.0X20MM NON-BSC BALLOON AND A 3.0X33MM NON-BSC STENT WAS DEPLOYED. FLOW IN THE LAD IMPROVED TO TIMI 2.5. MULTIPLE DILATATIONS THROUGHOUT MOST OF THE RCA WERE MADE USING A 3.0X20 NON-BSC MM BALLOON. FLOW WAS IMPROVED FOR TIMI 0 TO TIMI 3. THE STENTS APPEARED WIDELY PATENT. A PACEMAKER WAS PLACED, HOWEVER, IT WOULD NOT CAPTURE DESPITE SETTING AND LOCATION OF PLACEMENT. A SWAN-GANZ CATHETER WAS PLACED. THE PT WAS TRANSFERRED TO THE CRITICAL CARE UNIT, WHERE GRADUALLY HE STARTED HAVING LONGER AND LONGER EPISODES OF ASYSTOLE, IN SPITE OF INJECTION OF ANOTHER INTRAVENOUS BOLUS OF ATROPINE. THE SYSTOLIC PRESSURE HAD DRIFTED DOWN TO 30, EVEN ON BALLOON COUNTERPULSATION 1:1. THE SITUATION WAS DISCUSSED WITH THE WIFE, WHO REQUESTED THAT THE PT NOT BE RESUSCITATED AGAIN. FOLLOWING THIS, HE GRADUALLY DRIFTED IN TO ASYSTOLE AND WAS PRONOUNCED DEAD AT 21:43 HOURS.

    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 2.50X16MM

    Patients

    Seq Age Sex Outcome Treatment
    1 Death CROSSSAIL BALLOON| VOYAGER BALLOON| CYPHER STENT