BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING STENT

    MDR report key: 763364 · Received September 14, 2006

    Report

    Report Number
    6000089-2006-01819
    Event Type
    Injury
    Date Received
    September 14, 2006
    Date of Event
    April 2, 2005
    Report Date
    April 2, 2005
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: A UNIT HAS NOT BEEN RETURNED FOR REVIEW, THEREFORE, A TECHNICAL ANALYSIS CANNOT BE CARRIED OUT. WITHOUT A RETURNED UNIT, IT IS NOT POSSIBLE TO CONFIRM HOW THE DEVICE MAY HAVE CONTRIBUTED TO THE COMPLAINT INCIDENT. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS PARTICULAR BATCH NAMELY TOP ASSEMBLY BATCH #4564699 FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS, AT THE TIME OF RELEASE TO DISTRIBUTION.

    Description of Event or Problem · 1

    CLINICAL STUDY . SAME CASE AS 6000089-2006-01888. IT WAS REPORTED THAT 150 WEEKS AND 5 DAYS AFTER A CORONARY ARTERY DRUG-ELUTING STENTING TREATMENT PROCEDURE, THE PATIENT HAD A MYOCARDIAL INFARCTION. THE INDEX PROCEDURE IDENTIFIED ONE 12MM LONG TARGET LESION IN THE MID RIGHT CORONARY ARTERY (RCA) WITH 80% STENOSIS AND A REFERENCE VESSEL DIAMETER OF 3MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3X16MM TAXUS EXPRESS DRUG ELUTING STENT. A GRADE A DISSECTION OCCURRED PROXIMAL TO THE TARGET LESION AND A 3X24MM BAILOUT STUDY STENT WAS PLACED, REDUCING THE STENOSIS TO 0%. THE PATIENT WAS DISCHARGED 1 DAY LATER ON PROTOCOL DOSES OF ASA AND PLAVIX. THE PATIENT FELL AT HOME 150 WEEKS AND 5 DAYS POST-INDEX PROCEDURE AND WAS BROUGHT TO THE EMERGENCY DEPARTMENT FOR COMPLAINT OF WEAKNESS SEVERAL DAYS AFTER CHEMOTHERAPY FOR LUNG CANCER. PER THE EMERGENCY ROOM NOTE, THE PATIENT'S CPK AND CPK-MB LEVELS WERE NOTED TO BE ELEVATED WHICH WAS THOUGHT TO BE FROM THE PATIENT'S FALL. ECG REVEALED SUPRAVENTRICULAR TACHYCARDIA WITH DIFFUSE ST DEPRESSION WHICH WAS TREATED MEDICALLY. PATIENT WAS ALSO TREATED WITH INTRAVENOUS HYDRATION AND A NEBULIZER TREATMENT. PER DISCHARGE SUMMARY, SUBSEQUENT ECG'S , CPK-MB AND TROPONIN WERE CONSISTENT WITH A NON Q-WAVE MYOCARDIAL INFARCTION. THE PATIENT WAS DISCHARGED ON ASA/PLAVIX 5 DAYS AFTER THE EVENT . THE PHYSICIAN INDICATED THE RELATIONSHIP OF THE MI TO THE STUDY STENT: UNKNOWN; THE RELATIONSHIP OF THE MI TO THE INDEX PROCEDURE: NOT RELATED; OF MI TO CO-MORBID PRIOR CONDITION: POSSIBLY; AND RELATIONSHIP OF MI TO NON-TARGET VESSEL: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING STENT DRUG COATED STENT NIQ BOSTON SCIENTIFIC CORP. 3.0X16MM 4564699

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L| R