BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1971640 · Received January 27, 2011

    Report

    Report Number
    2134265-2011-00087
    Event Type
    Injury
    Date Received
    January 27, 2011
    Date of Event
    December 31, 2010
    Report Date
    January 7, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. IF THERE IS ANY FURTHER RELEVANT INFORMATION TO REPORT, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, STENT THROMBOSIS OCCURRED. ACCESS WAS OBTAINED THROUGH THE RIGHT FEMORAL ARTERY. FIRST, THE TARGET LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WAS TREATED. A 3.5X12MM NON-BSC STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AND THE STENT WAS DEPLOYED AT 16ATMS/30SEC. NEXT, THE TARGET LESION IN THE DIAGONAL (DX) ARTERY WAS TREATED. A 2.25X12MM TAXUS LIBERTE SDS WAS ADVANCED ON A .014 LUGE GUIDEWIRE AND THE STENT WAS DEPLOYED AT 14ATMS/30SEC. POST DILATATION WAS PERFORMED WITH A 2.5X8MM APEX CORONARY BALLOON INFLATED IN THE DX FOR 16ATMS/10SEC, 10ATMS/7SEC, 12ATMS/25SEC AND 16ATM/40SEC. THREE DAYS LATER, THE PATIENT PRESENTED WITH A TOTALLY OCCLUDED STENT. ANGIOGRAPHY WAS PERFORMED AND IT APPEARED THAT THERE WAS SOME PLAQUE SHIFT AT THE PROXIMAL END OF THE STENT IN THE DX AND THERE WAS POSSIBLE STENT THROMBOSIS. ANGIOMAX WAS ADMINISTERED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE UNK433

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention 3.5X12MM XIENCE STENT| .014 LUGE GUIDEWIRE| 2.5X8MM APEX CORONARY BALLOON| JUDKINS 5FR SHEATH