BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1053606 · Received May 23, 2008

    Report

    Report Number
    2134265-2008-01491
    Event Type
    Injury
    Date Received
    May 23, 2008
    Date of Event
    May 5, 2008
    Report Date
    May 5, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 WOULD 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 INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT # 2134265-2008-01492. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, ACUTE THROMBOSIS OCCURRED. THE "HIGH GRADE" TARGET LESIONS WERE IN THE DIAGONAL (DIAG) AND LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERIES. THE DIAG WAS PREDILATED WITH A 2.5X20MM MAVERICK BALLOON CATHETER. A 2.5X20MM TAXUS EXPRESS2 DRUG ELUTING STENT (DES) WAS IMPLANTED IN THE MID TO PROXIMAL DIAG. THE LAD AT THE BIFURCATION OF THE LAD AND DIAG WAS PREDILATED WITH A 2.5X20MM MAVERICK BALLOON CATHETER. A 3.0X20MM TAXUS EXPRESS2 DES WAS IMPLANTED IN THE LAD. THE 2.5X20MM TAXUS EXPRESS2 DES WAS POSTDILATED WITH A 2.5X15MM QUANTUM MAVERICK BALLOON CATHETER AND A 2.5X8MM QUANTUM MAVERICK BALLOON CATHETER. THE 3.0X20MM TAXUS EXPRESS2 DES WAS POSTDILATED WITH A 3.0X15MM QUANTUM MAVERICK BALLOON CATHETER. THE PROCEDURE WAS CONSIDERED TO HAVE A "VERY NICE RESULT". THE PT WAS SENT TO POST-OP AND APPROXIMATELY AN HOUR LATER, THE PT EXPERIENCED SHOULDER AND CHEST PAIN. ANGIOGRAPHY REVEALED THAT BOTH PREVIOUSLY IMPLANTED TAXUS EXPRESS2 DES HAD THROMBOSED. THE THROMBOSIS WAS TREATED WITH A NON-BSC ASPIRATION CATHETER. A 3.0X32MM TAXUS EXPRESS2 DES AND A 3.0X20MM TAXUS EXPRESS2 DES WERE IMPLANTED IN UNSPECIFIED LOCATIONS. THE LAD AND DIAG WERE POSTDILATED WITH A 3.0X8MM QUANTUM BALLOON CATHETER AND A 3.0X13MM NON-BSC BALLOON CATHETER. THERE WERE NO ADD'L PT COMPLICATIONS REPORTED WITH THE PT'S CURRENT CONDITION LISTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM NIQ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC 3.0X20MM

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R