BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL DRUG ELUTING STENT

    MDR report key: 729752 · Received June 26, 2006

    Report

    Report Number
    6000089-2006-01289
    Event Type
    Death
    Date Received
    June 26, 2006
    Date of Event
    May 9, 2005
    Report Date
    June 5, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINTANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL, THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT. SHOULD FURTHER RELEVANT INFO BECOMES AVAILABLE; A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 58 WEEKS AND 3 DAYS AFTER A CORONARY ARTERY DRUG-ELUTING STENTING TREATMENT PROCEDURE THE PT EXPIRED. THE INDEX PROCEDURE TREATED 1 DE NOVO TARGET LESION. THE TARGET LESION WAS A 3.5MM VESSEL DIAMETER, 10MM LONG, WITH NO CALCIFICATION, AND 95% STENOSIS, REGION OF THE MID RIGHT CORONARY ARTERY. THE LESION WAS PREDILATED WITH AN ANGIOPLASTY BALLOON AT 8 ATMS. POST PRE-DILATATION STENOSIS WAS 25%. THE PHYSICIAN SUCCESSFULLY IMPLANTED 1 TAXUS EXPRESS2 3.5X20MM DRUG-ELUTING STENT (DES) AT 14 ATMS. POST-TREATMENT, THE LESIONS WERE 0% STENOSIS AND TIMI 3 FLOW. ANGIOPLASTY WAS THEN PERFORMED TO THE LCX, AND A 2.0 X 23MM PIXEL STENT WAS DEPLOYED IN THE MID LCX. THE PT WAS DISCHARGED 1 DAY POST-INDEX PROCEDURE ON ASPIRIN AND CLOPIDOGREL. THE PT PRESENTED TO THE ER IN 2004 AND WAS ADMITTED WITH PRESUMED PNEUMONIA. HE WAS TREATED FOR PNEUMONIA AND COPD EXACERBATION WITH OXYGEN, ANTIBIOTICS AND SOLUMEDROL WAS RECOMMENDED. IN 2005, THE PT PRESENTED TO THE ER FOR EVAL OF ACUTE RESPIRATORY FAILURE. THE PT WAS STABILIZED IN THE ER AND DIAGNOSED WITH A COPD EXACERBATION. CXR ON ADMISSION WAS UNCHANGED FROM PREVIOUS X-RAYS. THE PT REQUIRED PROLONGED IV AMINOPHYLLINE WITH SECONDARY SIDE EFFECT OF PSVT. THE PT WAS DISCHAGED 16 DAYS LATER. THE PT WAS READMITTED THE NEXT MONTH FOR INCREASED SHORTNESS OF BREATH. CXR REVEALED POSSIBLE LEFT LOWER LOBE CONSOLIDATION. PT WAS DIAGNOSED WITH COPD EXACERBATION AND WAS TREATED WITH ANTIBIOTICS. THE PT'S RESPIRATORY STATUS CONTINUED TO DECLINE THROUGHOUT THE ADMISSION. FOURTEEN DAYS LATER, THE PT'S HEMOGLOBIN WAS NOTED TO HAVE DECLINED FROM 12.4 TO 8.0 AND THE PT HAD HEMOCCULT POSITIVE STOOL. THE PT WAS NOT TRANSFUSED, DUE TO RELIGIOUS REASONS. IT WAS RECOMMENDED TO INCREASE ERYTHROPOIETIN AND GI WAS CONSULTED. ON THE FOLLOWING MONTH , GI CONSULTATION RECOMMENDED EMPIRIC IV PPI THERAPY AND UPPER AND LOWER ENDOSCOPIES. EIGHT DAYS LATER, THE PT SUSTAINED A CARDIOPULMONARY ARREST. THE PT WAS INTUBATED AND PLACED ON MECHANICAL VENTILATION. TEMP AT THAT TIME WAS ELEVATED TO 102F. FEVER PERSISTED AND BLOOD CULTURES WERE POSITIVE FOR PSEUDOMONAS FLUORESCENS. ID WAS CONSULTED AND FELT THAT THE PT WAS SEPTIC SECONDARY TO PSEUDOMONAS WITH THE CENTRAL VENOUS CATHETER AS THE MOST LIKELY SOURCE. CATHETER REMOVAL AND IV ANTIBIOTICS WERE RECOMMENDED. TWENTY DAYS LATER THE PT WAS TRANSFERRED TO A NURSING HOME FOR COMPLETION OF IV ANTIBIOTICS WITH CONSIDERATION OF FUTURE HOSPICE CARE. THE PT'S OVERALL PROGNOSIS WAS NOTED TO BE POOR. THE PT EXPIRED 58 WEEKS AND 3 DAYS AFTER THE INDEX PROCEDURE WITH THE CAUSE OF DEATH INDICATED AS RESPIRATORY FAILURE. NO AUTOPSY WAS PERFORMED. NO FURTHER INFO IS AVAILABLE. THE PHYSICIAN INDICATED TARGET VESSEL INVOLVEMENT AS NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL DRUG ELUTING STENT DRUG ELUTING STENT NIQ BOSTON SCIENTIFIC CORP. 3.5X20MM 6223504

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death