BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1882136 · Received October 25, 2010

    Report

    Report Number
    2134265-2010-04691
    Event Type
    Injury
    Date Received
    October 25, 2010
    Date of Event
    May 31, 2007
    Report Date
    October 4, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. IF IMPLANTED, GIVE DATE - 2004. DEVICE EVALUATED BY MANUFACTURER - THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT#: 2134265-2010-04695. IT WAS REPORTED THAT POST A CORONARY STENTING TREATMENT PROCEDURE, A MYOCARDIAL INFARCTION, STROKE AND STENT OCCLUSION OCCURRED. THE LESION WAS LOCATED IN THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING ARTERY (LAD.) TWO TAXUS EXPRESS2 STENTS OF UNKNOWN SIZE WERE PLACED IN THE LESION. NO PATIENT COMPLICATIONS WERE REPORTED. APPROXIMATELY THREE YEARS LATER THE PATIENT PRESENTED TO THE EMERGENCY ROOM UNRESPONSIVE, WITH SONOROUS RESPIRATIONS, BRADYCARDIA, A NON-ST ELEVATION MYOCARDIAL INFARCTION AND STROKE. THE TAXUS EXPRESS2 STENT PLACED IN THE PROXIMAL THIRD OF THE LAD WAS 30% STENOSED. A NARROWING BETWEEN THE STENTS SHOWED 40% STENOSIS. THE MID LAD STENT WAS WIDELY PATENT; HOWEVER, THE DISTAL EDGE OF THE STENT WAS 90% STENOSED. ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. A 2.5X12MM TAXUS EXPRESS2 STENT WAS DEPLOYED AT 12 ATMS. THE STENT WAS POST-DILATED WITH A 3.0X9MM MAVERICK BALLOON INFLATED TO 10-12 ATMS. RESIDUAL STENOSIS WAS REDUCED TO LESS THAN 5%. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT WAS DISCHARGED ON ASPIRIN, PLAVIX, COLASE, PEPCID, LOPRESSOR, RAMIPRIL AND CRESTOR. THE PATIENT HAS BEEN TAKING PLAVIX SINCE THE REINTERVENTION AND REMAINS SYMPTOM FREE. PATIENT STATUS IS LISTED AS OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE UNK432

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention