BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2173451 · Received July 23, 2011

    Report

    Report Number
    2134265-2011-02935
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 25, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. IF IMPLANTED, GIVE DATE: 2007. DEVICE EVALUATED BY MANUFACTURER. IT IS 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 PATIENT AS MFR # 2134265-2011-02753, 2134265-2011-02734. SAME CASE AS MFR# 2134265-2011-02934, 2134265-2011-02941. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, RESTENOSIS OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THREE TAXUS EXPRESS2 STENTS, SIZE 3.0X12MM, 3.0X32MM, AND 2.5X24MM, WERE IMPLANTED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. TWO YEARS LATER, A 3.5X18MM NON-BSC STENT WAS PLACED IN THE PROXIMAL LAD. TWO YEARS LATER, IN-STENT RESTENOSIS WAS NOTED IN. IVUS WAS NOT PERFORMED. PLAIN OLD BALLOON ANGIOPLASTY WAS PERFORMED TO TREAT IN-STENT RESTENOSIS OF THE LAD. WHILE ADVANCING A 20X2.0MM MAVERICK2 MONORAIL BALLOON CATHETER RESISTANCE WAS ENCOUNTERED PROXIMAL TO THE 3.5X18MM NON-BSC STENT. THE BALLOON CATHETER CROSSED THE TARGET LESION, HOWEVER PRIOR TO INFLATION, WHEN APPLYING NEGATIVE PRESSURE "BLOOD FLEW BACK". THE PHYSICIAN SUSPECTED THAT THE BALLOON HAD ALREADY RUPTURED. THE DEVICE WAS REMOVED INTACT AND EXCHANGED FOR ANOTHER 20X2.0MM MAVERICK2 BALLOON CATHETER. THE 20X2.0MM MAVERICK2 CATHETER WAS ADVANCED TO THE LESION AND AGAIN PRIOR TO INFLATION, "BLOOD FLEW BACK". IT WAS NOTED THAT THIS BALLOON HAD ALSO RUPTURED. THE MAVERICK2 CATHETER WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH A FLEXTOME AND NON-BSC CUTTING BALLOON. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    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 - GALWAY H7493897032300

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention