BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1012358 · Received February 12, 2008

    Report

    Report Number
    2134265-2008-00733
    Event Type
    Death
    Date Received
    February 12, 2008
    Date of Event
    February 12, 2008
    Report Date
    February 13, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2008-00747, 2134265-2008-00734. IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, A STENT THROMBOSIS, CARDIOGENIC SHOCK AND PATIENT DEATH OCCURRED. THE 90% STENOSED LESION BEING TREATED WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH A TIMI FLOW OF 3, AND THE 100% STENOSED PROXIMAL CIRCUMFLEX (CX) ARTERY WITH A TIMI FLOW OF 0. THE LAD LESION WAS PREDILATED WITH A 2.5X15MM NON-BSC BALLOON, INFLATED TO 8 ATM FOR 25 SECONDS. THE PHYSICIAN PLACED A 2.50X16MM TAXUS EXPRESS2 DRUG ELUTING STENT IN THE PROXIMAL LAD, INFLATING TWICE TO 13-14 ATM FOR 25 SECONDS. THE STENOSIS WAS REDUCED TO 0% AND TIMI FLOW WAS 3. THEN THE CX LESION WAS PREDILATED WITH A 2.0X15MM NON-BSC BALLOON, INFLATED TWICE TO 14 ATM FOR 20-30 SECONDS. THE PHYSICIAN ATTEMPTED TO PLACE A 2.75X32MM TAXUS EXPRESS2 DRUG ELUTING STENT IN THE PROXIMAL CX, BUT WAS UNABLE TO CROSS THE LESION. THE 2.5X15MM NON-BSC BALLOON WAS INFLATED TWICE TO 7 ATM FOR 11-15 SECONDS. THE PHYSICIAN PLACED A 2.75X32MM TAXUS EXPRESS2 DRUG ELUTING STENT IN THE PROXIMAL CX, INFLATING TWICE TO 9-20 ATM FOR 20 SECONDS. THE STENT WAS POST DILATED WITH A 2.5X8MM NON-BSC BALLOON, INFLATED TWICE TO 18-19 ATM FOR 15-25 SECONDS. THE STENOSIS WAS REDUCED TO 0% WITH A TIMI FLOW OF 3. MEDICATIONS GIVEN: ANGIOMAX, NTG, HEPARIN. THE FOLLOWING DAY, THE PATIENT PRESENTED WITH CHEST PAIN AND ST SEGMENT ELEVATED MYOCARDIAL INFARCTION. THE MID AND PROXIMAL LAD WERE FOUND TO BE 100% OCCLUDED WITH A TIMI FLOW OF 0. MULTIPLE INFLATIONS WERE MADE WITH A 2.5X15MM MAVERICK BALLOON, INFLATED TO 6-16 ATM FOR 10-30 SECONDS. THE PHYSICIAN PLACED A 3.00X12MM TAXUS EXPRESS2 DRUG ELUTING STENT, INFLATED TWICE TO 9 ATM FOR 15-20 SECONDS. THE STENOSIS WAS REDUCED TO 0% WITH A TIMI FLOW OF 3. MEDICATIONS GIVEN: INTEGRILIN, HEPARIN. PATIENT WAS PLACED ON CPAP AND TRANSFERRED TO A HOLDING AREA AWAITING A BED IN ICU. THREE HOURS POST THE REINTERVENTION, THE PATIENT PRESENTED WITH CARDIOGENIC SHOCK AND WAS INTUBATED. ALL VESSELS HAD SHUT DOWN. AN ACUTE CLOSURE OF THE LAD WAS IDENTIFIED. MEDICATIONS GIVEN: INTEGRILIN, HEPARIN, ATROPINE, DOPAMINE, ADENOSINE, EPINEPHRINE, CALCIUM GLUCONATE. A CODE WAS CALLED, ALL DRIPS WERE DISCONTINUED, AND THE VENT WAS TURNED OFF. FLOW COULD NOT BE REESTABLISHED AND THE PATIENT DIED FROM CARDIOGENIC SHOCK.

    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 2.50X16 MM

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R MEDTRONIC GUIDE CATHETER| COPILOT BLEEDBACK CONTROL VALVE| MERIT INDEFLATOR| POWERSAIL BALLOON| RX VOYAGER BALLOON| CHOICE EXTRA SUPPORT GUIDEWIRE