BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING STENT

    MDR report key: 759246 · Received September 8, 2006

    Report

    Report Number
    6000093-2006-01788
    Event Type
    Death
    Date Received
    September 8, 2006
    Date of Event
    August 7, 2006
    Report Date
    August 15, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DELIVERY DEVICE WAS DISPOSED AND THE STENT REMAINED IN THE PATIENT. THEREFORE NO ANALYSIS COULD BE PERFORMED. THE REPORTED BATCH NUMBER 8093974 WAS REWORKED FROM TOP ASSEMBLY BATCH NUMBER 7665829. THE MANUFACTURING RECORDS FOR TOP ASSEMBLY BATCH 7665829 HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. 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 25 DAYS AFTER A CORONARY ARTERY DRUG-ELUTING STENTING TREATMENT PROCEDURE, THE PATIENT EXPIRED. THE INDEX PROCEDURE TREATED 1 TARGET LESION. THE PATIENT ALREADY HAD ATRIAL FIBRILLATION ENTERING THE ER. THE PATIENT HAD RENAL INSUFFICIENCY, DUE TO IDDM WITH REGULAR NEED OF HEMODIALYSIS (HD). THE PATIENT HAD "ANURIA DUE TO TERMINAL RENAL INSUFFICIENCY, DIDN'T HAVE HD FOR 2 DAYS." THE PHYSICIAN PLACED A 4.0X16MM TAXUS EXPRESS2 DRUG-ELUTING STENT IN THE DISTAL RIGHT CORONARY ARTERY. THE PHYSICIAN OBSERVED A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY AND LEFT CIRCUMFLEX (LCX) AT THAT TIME, BUT DID NOT TREAT. THE PATIENT RETURNED WITH RE-INFARCTION AND VENTRICULAR FIBRILLATION 25 DAYS POST-INDEX PROCEDURE. "OUT OF STABLE CONDITIONS OVER 3 WEEKS." SUDDENLY VENTRICULAR TACHYCARDIA (VT) WITH HEMODYNAMIC INSTABILITY AND VENTRICULAR FIBRILLATION (VF). IN TOTAL THERE WAS 2 HOURS OF CPR WITH MULTIPLE MEDICATIONS ADMINISTERED INCLUDING AMIODARONE, ADRENALIN, AND ATROPINE. "NO STABILIZATION AFTER SEVERAL DEFIBRILLATIONS. RESCUE LYSIS W 100MG ACTILYSE W/O SUCCESS. DIED AT 6:05." ON MONITOR ST ELEVATED NOT TO BE SAID WHERE. "POSSIBLE STENT THROMBOSIS (CLOPIDOGREL REGULARLY TAKEN) ALSO POSSIBLE OCCLUSION OF LCX OR LAD WHICH STILL HAS XX SEVERE STENOSIS. UNFORTUNATELY RELATIVE DISAGREED (SIC) ON AUTOPSY. ALSO POSSIBILITY OF LUNG 'EMBOLISM,' BUT IN EMERGENCY ULTRASOUND SMALL RIGHT VENTRICLE, NOT VERY PROBABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING STENT DRUG COATED STENT NIQ BOSTON SCIENTIFIC CORP. 4.0X16MM 7665829

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Death