BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1080876 · Received July 23, 2008

    Report

    Report Number
    2134265-2008-02075
    Event Type
    Death
    Date Received
    July 23, 2008
    Date of Event
    August 14, 2008
    Report Date
    June 26, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    K030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO DEVICE WAS REC'D FOR ANALYSIS, IT IS NOT POSSIBLE TO PERFORM ANY INSPECTIONS ON THE DEVICE. THEREFORE, IT IS NOT POSSIBLE TO DETERMINE IF ANY ISSUES EXISTED WITH THE ACTUAL UNIT THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT. AS THE BATCH NUMBER IS UNKNOWN, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CARRIED OUT. THE ROOT CAUSE WILL BE DOCUMENTED AS ANTICIPATED PROCEDURAL COMPLICATION DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE NOTED WITHIN THE DIRECTIONS FOR USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, A STENT OCCLUSION AND DEATH OCCURRED. THE PT PRESENTED TO THE EMERGENCY ROOM IN CARDIOPULMONARY ARREST AFTER EXPERIENCING NAUSEA AND VOMITING DURING THE NIGHT. IN THE ER THE PATIENT CONTINUED TO HAVE MULTIPLE EPISODES OF VOMITING WHICH APPEAR TO BE COFFEE GROUND EMESIS. A RIGHT FEMORAL LINE WAS PLACED AND THE PT WAS AGGRESSIVELY HYDRATED. FIVE DAYS LATER, THE PT WAS BROUGHT TO THE CCL WHERE AN 80% STENOSED LESION WAS LOCATED IN MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. A TAXUS EXPRESS2 2.5X24MM DRUG ELUTING STENT WAS DEPLOYED AT 13 ATM'S FOR 37 SECONDS AND THE BALLOON WAS REINFLATED TO 13 ATM'S FOR 3 SECONDS. THERE WAS 0% RESIDUAL STENOSIS AND TIMI FLOW 3 WAS ESTABLISHED. THE SHEATH WAS SUTURED INTO PLACE. NO COMPLICATIONS OCCURRED. ANGIOMAX WAS ADMINISTERED DURING THE PROCEDURE. APPROXIMATELY 4 MONTHS LATER, DURING THE NIGHT, THE PT'S SPOUSE WITNESSED HER GOING INTO CARDIOPULMONARY ARREST AT HOME. CPR WAS PERFORMED AND THE PT WAS TRANSPORTED TO THE HOSP. SHE WAS FOUND TO HAVE A HYPERACUTE ANTERIOR MI. CURRENT MEDICATIONS INCLUDED PLAVIX AND A BABY ASPIRIN. THE PT WAS INTUBATED AND HER PUPILS WERE FIXED AND DILATED. NO MEANINGFUL PURPOSEFUL MOVEMENT WAS PRESENT. PER THE PHYSICIAN NOTES "I AM CONCERNED THAT SHE DOES NOT HAVE MUCH NEURO FUNCTION AND MAY HAVE SOME PERMANENT DAMAGE, HOWEVER, I DO FEEL CORONARY ANGIOGRAPHY WOULD BE INDICATED AT THIS TIME." AN EMERGENT CATH WAS PERFORMED AND THE PREVIOUSLY PLACED STENT WAS FOUND TO BE 100% OCCLUDED. A 2.5X15MM MAVERICK2 BALLOON WAS INFLATED TO 3, 6 AND 10 ATM'S FOR 6 SECONDS EACH. NEXT, A TAXUS EXPRESS2 3.0X28MM STENT WAS PLACED IN THE MID LAD, INFLATING THE BALLOON TO 15 ATM'S FOR 13 SECONDS AND 10 ATM'S FOR 10 SECONDS. EF WAS FOUND TO BE 35% WITH DISTAL ANTERIOR AND APICAL AKINESIS. NO COMPLICATIONS OCCURRED DURING THE PROCEDURE. POST CARDIAC CATHETERIZATION, THE PT REMAINED UNRESPONSIVE AND COMPLETELY VENTILATOR DEPENDENT. PATIENT DID BECOME HEMODYNAMICALLY STABLE, HOWEVER, SHE CONTINUED TO HAVE NO RESPONSE TO STIMULI WITH SLUGGISH PUPILS. SHE WAS FELT TO HAVE ANOXIC ENCEPHALOPATHY AND A POOR PROGNOSIS. TWO DAYS POST REINTERVENTION, THE FAMILY OPTED TO MAKE HER COMFORT MEASURES ONLY AND INITIATED A DNR. A TERMINAL WEAN WAS INITIATED AND THE PT EXPIRED.

    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 2.5X24MM

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R