BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT

    MDR report key: 758193 · Received September 5, 2006

    Report

    Report Number
    6000093-2006-01738
    Event Type
    Death
    Date Received
    September 5, 2006
    Date of Event
    August 1, 2006
    Report Date
    August 9, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELIVERY DEVICE WAS DISPOSED AND THE STENT REMAINED IN THE PATIENT. THEREFORE, NO ANALYSIS COULD BE PERFORMED. BECAUSE THE BATCH NUMBER FOR THIS COMPLAINT IS UNKNOWN, THE SHOP FLOOR PAPERWORK COULD NOT BE EXAMINED. THE CAUSE OF THE DIFFICULTIES EXPERIENCED DURING THE PROCEDURE COULD NOT BE DETERMINED. BOSTON SCIENTIFIC MANUFACTURING PROCESSES INCLUDE EXTENSIVE TESTING AND INSPECTIONS TO ENSURE EACH PRODUCT MEETS OR EXCEEDS MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOUR DAYS AFTER A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, A PATIENT DIED. THE LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 7 FRENCH 10 CM SHEATH WAS USED TO ACCESS THE LEFT FEMORAL ARTERY (LFA). A 7 FRENCH XB 3.5 GUIDE CATHETER WAS INSERTED AND THE CORONARY ARTERY VEIN GRAFT WERE VISUALIZED. A COUGAR LAS 0.014X300 CM GUIDEWIRE WAS ADVANCED AND CROSSED THE LESION SITE. NEXT, THE PHYSICIAN SUCCESSFULLY ADVANCED AND DEPLOYED A TAXUS EXPRESS2 3.00X16.0MM MONORAIL DRUG ELUTING STENT (DES) AT 13 ATMS FOR 25 SECONDS. THE AREA WAS NOT PRE-DILATED. THE ENTIRE STENT DELIVERY SYSTEM (SDS) AND GUIDEWIRE WAS REMOVED. THE SHEATH WAS SUTURED IN PLACE AND HEMOSTASIS WAS OBTAINED. THERE WERE NO PATIENT COMPLICATIONS DURING THE PROCEDURE. MEDICATIONS ADMINISTERED PRIOR TO THE PROCEDURE WERE VERSED, FENTANYL AND LIDOCAINE; DURING THE PROCEDURE FENTANYL AND ANGIOMAX; AND POST-PROCEDURE PLAVIX WAS ADMINISTERED. THREE DAYS LATER, THE PATIENT RETURNED TO THE HOSPITAL WITH ACUTE THROMBOSIS. WITHIN 2-3 MINUTES OF ARRIVAL, THE PATIENT CODED. CARDIO PULMONARY RESUSCITATION (CPR) WAS PERFORMED. PRIOR TO BEGINNING TREATMENT, THE PATIENT WAS UNABLE TO MOVE EXTREMITIES VOLUNTARILY OR UPON COMMAND AND WAS NOT RESPONDING. A 6 FRENCH VISTA JL4 GUIDE CATHETER WAS INTRODUCED AND THEN A PILOT 50 190CM GUIDEWIRE WAS ADVANCED. A MAVERICK 2.50X12.0MM BALLOON WAS ADVANCED TO THE PROXIMAL LAD AND DILATED AT 8 ATMS FOR 10 SECONDS AND AGAIN AT 6 ATMS FOR 10 SECONDS. CPR WAS CONTINUED. AGAIN, THE BALLOON WAS INFLATED AT 0 ATMS FOR 86 SECONDS. A NEW MAVERICK 3.00X30.0MM BALLOON WAS ADVANCED TO THE PROXIMAL LAD AND DILATED AT 10 ATMS FOR 20 SECONDS, THE BALLOON WAS THEN REMOVED AND THE DIVER ASPIRATION CATHETER WAS INTRODUCED TO REMOVE THE CLOTS. CPR WAS CONTINUED. IVUS ATLANTIS PRO SR 40 MHZ/135.0CM WAS INTRODUCED ADVANCED DISTALLY TO THE STENT. THE ARTERY WAS VISUALIZED. THE PHYSICIAN THEN ADVANCED A VISION 3.50X18.0MM BARE METAL STENT AND DEPLOYED SUCCESSFULLY AT 11 ATMS FOR 20 SECONDS IN THE PROXIMAL LAD. THE STENT WAS POST-DILATED WITH A QUANTUM MAVERICK 4.00X20.0MM BALLOON AT 15 ATMS FOR 12 SECONDS, 14 ATMS FOR 12 SECONDS AND 14 ATMS FOR 20 SECONDS. THE PROCEDURE WAS COMPLETED AND HEMOSTASIS WAS OBTAINED. THE PATIENT CONDITION WAS REPORTED AS "PATIENT EYES CLOSED, EYELIDS BLACK AND BLUE AND APPEARED DARKER THAN THEY WERE PRIOR TO THE PROCEDURE" AND THEN THE PATIENT WAS TRANSPORTED TO THE CARDIOVASCULAR INTENSIVE CARE UNIT UNDER CONSCIOUS SEDATION. DURING THE PROCEDURE, COMPLICATIONS INCLUDED VENTRICULAR FIBRILLATION, VENTRICULAR TACHYCARDIA, CODE ARREST AND CARDIOGENIC SHOCK. MEDICATIONS ADMINISTERED PRIOR TO THE TREATMENT PROCEDURE WERE LIDOCAINE; DURING THE PROCEDURE SODIUM BICARBONATE, ATROPINE, EPINEPHRINE, AMIODARONE, HEPARIN, REOPRO, LEVOPHED, VERSED AND LASIX; AND POST-PROCEDURE DOPAMINE AND VERSED WERE ADMINISTERED. THE NEXT DAY, THE PATIENT DIED. SEVERAL ATTEMPTS TO OBTAIN FOLLOW-UP INFORMATION CONCERNING THE PATIENT DEATH HAVE BEEN MADE, BUT NOT RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT DRUG COATED STENT NIQ BOSTON SCIENTIFIC CORP. 3.00X16.0MM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death