BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1220464 · Received November 4, 2008

    Report

    Report Number
    2134265-2008-04211
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    October 8, 2008
    Report Date
    October 13, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, A STENT DISLODGEMENT OCCURRED. THE PATIENT PRESENTED EMERGENTLY FOR CARDIAC CATHETERIZATION. THE TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). MULTIPLE PTCA BALLOONS WERE INSERTED AND REMOVED AND THE LESION WAS FINALLY PREDILATED WITH A 3.0X9MM MAVERICK BALLOON. TWO INFLATIONS TO 14 ATM'S WERE MADE AND A NON-BSC STENT WAS THEN IMPLANTED. A 3.5X12MM LIBERTE' STENT WAS THEN INSERTED AND REMOVED, WITHOUT BEING DEPLOYED. A 3.0X15MM QUANTUM MAVERICK BALLOON WAS INFLATED TO 12 ATM'S FOR 40 SECONDS TO PREDILATE THE PROXIMAL RCA. THE 3.5X8MM LIBERTE' BARE METAL STENT WAS THEN INSERTED. THE STENT DELIVERY SYSTEM WAS UNABLE TO CROSS THE LESION, HOWEVER, WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE DEVICE, THE STENT WAS STUCK IN THE LESION AND CAME OFF THE BALLOON. MULTIPLE BALLOONS WERE INSERTED IN AN ATTEMPT TO DEPLOY IT, BUT THESE MANEUVERS WERE UNSUCCESSFUL. A 3.5X8MM QUANTUM MAVERICK BALLOON WAS INFLATED AND A 3.5X12MM LIBERTE' STENT WAS IMPLANTED. THE PATIENT BEGAN TO EXPERIENCE ST ELEVATIONS AND HAD COMPLAINTS OF 10/10 CHEST PAIN. ANGIOGRAPHY WAS PERFORMED AND THE CHEST PAIN WAS RESOLVING. IC NTG WAS STARTED AND ST SEGMENTS RETURNED TO BASELINE. IT WAS DECIDED THAT THE PATIENT WOULD BE TRANSFERRED TO ANOTHER FACILITY FOR TREATMENT. NO FURTHER PATIENT COMPLICATIONS OCCURRED. PATIENT STATUS IS REPORTED TO BE SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM MAF STENT, CORONARY MAF BOSTON SCIENTIFIC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention