BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL - ELUTING STENT

    MDR report key: 755317 · Received August 24, 2006

    Report

    Report Number
    6000093-2006-01616
    Event Type
    Death
    Date Received
    August 24, 2006
    Date of Event
    May 10, 2005
    Report Date
    August 1, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 UNK, THE SHOP FLOOR PAPERWORK COULD NOT BE EXAMINED. THE CAUSE OF THE DIFFICULTIES EXPERIENCED DURING THE PROCEDURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    CLINICAL STUDY. IT WAS REPORTED THAT 2 DAYS AFTER A CORONARY ARTERY DRUG-ELUTING STENTING TREATMENT PROCEDURE, THE PATIENT EXPIRED. INFORMATION RECEIVED INDICATED THAT 2 DAYS AFTER THE INDEX PROCEDURE AND PRIOR TO DISCHARGE THE PATIENT EXPIRED. THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM AFTER COMPLAINING OF FEELING WEAK DIAPHORETIC, AND SWEATY. THE PATIENT WAS RULED IN FOR A MYOCARDIAL INFARCTION AND ECG SHOWED A ST ELEVATION AND ANTERIOR EPICARDIAL LEADS. SHE WAS TAKEN TO THE CARDIAC CATHETERIZATION LAB (CCL). THE INDEX PROCEDURE TREATED 1 DE NOVO BIFURCATED 80% STENOSED TARGET LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY. THE LESION WAS PREDILATED WITH AN ANGIOPLASTY BALLOON AT 6 ATMS. THE PHYSICIAN SUCCESSFULLY IMPLANTED A 3X16MM TAXUS EXPRESS2 DRUG-ELUTING STENT AT 12 ATMS. POST IMPLANT STENOSIS WAS 0% WITH TIMI FLOW 3. AFTER BEING TRANSFERRED TO THE CARDIAC CARE UNIT (CCU), SHE DEVELOPED HYPOTENSION AS WELL AS CHEST PAIN. SHE WAS TAKEN BACK TO THE CCL THE SAME NIGHT FOR RE-EVALUATION. THIS SHOWED PATIENT LEFT ANTERIOR DESCENDING ARTERY AND NO CHANGE COMPARED TO THE PREVIOUS CARDIAC CATHETERIZATION. HOWEVER, HER BLOOD PRESSURE WAS STILL LOW; SYSTOLIC BLOOD PRESSURE IN THE 40S, SO SHE WAS PLACED ON THE INTRA-AORTIC BALLOON PUMP, INTUBATED, AND READMITTED TO THE CCU. "THE PICTURE WAS THAT OF CARDIOGENIC SHOCK. SHE WAS PLACED ON LOPRESSOR, DOPAMINE DRIP AND DOBUTAMINE. HER AUGMENTED BLOOD PRESSURE ON THE BALLOON PUMP WAS BETWEEN 82 TO 100. THE SYSTOLIC BLOOD PRESSURE WITHOUT THE BALLOON PUMP REMAINED IN THE 40'S AND SHE BECAME MORE TACHYCARDIAC THE NEXT MORNING WITH THE HEART RATE GOING UP TO 120S AND TO 150S. THE DOPAMINE WAS WEANED OFF AND WE REPLACED IT WITH LEVOPHED, TITRATED UP FOR HER BLOOD PRESSURE. HER ARTERIAL BLOOD GAS AFTER INTUBATION IMPROVED WITH THE PH OF 7.3; PC02 33; P02 OF 157 ON FIV SETTING." HER URINE OUTPUT WAS LOW, SHE ONLY PUT OUT 5 CC PER HOUR, "SO THIS IS LIKELY THAT SHE HAS DECREASED KIDNEY FUNCTION DUE TO HYPERFUSION AND HER BUN AND CREATININE WENT UP TO BUN OF 40 AND CREATININE OF 1.8. THE PATIENT CONTINUED TO BE IN CRITICAL CONDITION THROUGHOUT THE DAY. SHE ALSO HAD EPISODES OF COFFEE GROUND EMESIS TWICE, BUT THIS CLEARED WITH NG LAVAGE." HER PLATELET COUNT WENT DOWN FROM 200 PROGRESSIVELY TO 68. SHE RECEIVED ONE UNIT OF PLATELETS AND ONE BACKUP CRYOPRECIPITATE. HER HEMATOCRIT ALSO DROPPED TO 25 AND SHE RECEIVED ONE UNIT OF BLOOD TRANSFUSION. SHE BEGAN DETERIORATING WITH HER ARTERIAL BLOOD GAS BECOMING MORE ACIDOTIC, DECREASED HEART RATE TO THE 40'S AND BLOOD PRESSURE 36/20. "AT THE FAMILY'S REQUEST, NO CPR WAS INITIATED. WE CONTINUED TO RESUSCITATE HER WITH CHEMICAL CODE AND SHE EXPIRED AT 5 A.M." THE PATIENT'S FAMILY DID NOT WISH TO HAVE AN AUTOPSY PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL - ELUTING STENT DRUG ELUTING STENT NIQ BOSTON SCIENTIFIC CORP. 3.0X16MM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death