BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 806061 · Received January 12, 2007

    Report

    Report Number
    6000093-2007-00097
    Event Type
    Injury
    Date Received
    January 12, 2007
    Date of Event
    December 13, 2006
    Report Date
    January 8, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE STENT REMAINS IMPLANTED AND THE DELIVERY DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT. BECAUSE THE BATCH NUMBER IS UNK, THE SHOP FLOOR PAPERWORK COULD NOT BE EXAMINED.

    Description of Event or Problem · 1

    SAME CASE AS MANUFACTURER'S REPORT # 6000093-2007-98 AND 6000093-2007-96. TAP. IT WAS REPORTED THAT 76 DAYS AFTER IMPLANTATION OF 3.0X12MM, 3.0X32MM, AND 2.5X24MM TAXUS EXPRESS2 DRUG ELUTING STENTS, IN-STENT RESTENOSES OCCURRED. DURING THE INITIAL PROCEDURE, THE TARGET LESIONS WERE LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) AND 1ST DIAGONAL (D1) ARTERIES. PRE-INTERVENTION STENOSES OF 70% IN THE LAD AND 80% IN D1 WERE NOTED. IT WAS NOT REPORTED THAT THE LESIONS WERE PRE-DILATED. PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTCA) WAS PERFORMED ON THE "HEAVILY CALCIFIED" LAD, FOLLOWED BY THE DEPLOYMENT OF 3.0X12MM AND 3.0X32MM TAXUS STENTS. IT WAS NOT REPORTED THAT THE STENTS WERE POST-DILATED. A POST-INTERVENTION RESIDUAL STENOSIS OF 0% WAS NOTED. PTCA WAS PERFORMED ON D1, FOLLOWED BY THE DEPLOYMENT OF A 2.5X24MM TAXUS STENT. IT WAS NOT REPORTED THAT THE STENT WAS POST-DILATED. A POST-INTERVENTION RESIDUAL STENOSIS OF 0% WAS REPORTED. IT WAS NOTED THAT THE PATIENT TOLERATED THE PROCEDURE "WELL." NO COMPLICATIONS WERE REPORTED. THE PATIENT PRESENTED 76 DAYS AFTER THE INITIAL PROCEDURE WITH A 98% IN-STENT RESTENOSIS IN THE PROXIMAL-TO-MID LAD AND A 95% IN-STENT RESTENOSIS IN D1. PTCA WAS PERFORMED ON THE LAD, FOLLOWED BY THE DEPLOYMENT OF 3.0X20MM AND 2.75X28MM TAXUS STENTS. A 2.5X24MM TAXUS STENT WAS THEN DEPLOYED IN THE LAD USING THE KISSING BALLOON TECHNIQUE. PTCA WAS PERFORMED ON D1, FOLLOWED BY THE DEPLOYMENT OF A 2.5X12MM TAXUS STENT. A 2.5X24MM TAXUS STENT WAS DEPLOYED IN D1 USING THE KISSING BALLOON TECHNIQUE. A POST-INTERVENTION RESIDUAL STENOSIS OF 0% WAS REPORTED IN BOTH THE LAD AND IN D1. THE PATIENT TOLERATED THE PROCEDURE "WELL." NO COMPLICATIONS WERE REPORTED.

    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 3.0X12MM *

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other| R