BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT

    MDR report key: 793441 · Received December 8, 2006

    Report

    Report Number
    6000093-2006-02558
    Event Type
    Injury
    Date Received
    December 8, 2006
    Date of Event
    November 10, 2006
    Report Date
    November 13, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    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

    H6: THE COMPLAINANT INDICATED THAT THE STENT REMAINS IMPLANTED AND THE DELIVERY DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT. THE MFG RECORDS FOR TOP ASSEMBLY BATCH 8160995 HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 203 DAYS AFTER IMPLANTATION OF A 3.0X32MM TAXUS EXPRESS2 DRUG ELUTING STENT, IN-STENT RESTENOSIS OCCURRED. DURING THE INITIAL PROCEDURE, THE TARGET LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). A PRE-INTERVENTION STENOSIS OF 85% WAS REPORTED. IT WAS NOT REPORTED THAT THE LESION WAS PREDILATED. A 3.0X32MM TAXUS EXPRESS2 DRUG ELUTING STENT WAS DEPLOYED IN THE REGION OF THE LESION. IT WAS NOT REPORTED THAT THE STENT WAS POST-DILATED. A POST-INTERVENTION RESIDUAL STENOSIS OF 0% WAS REPORTED. THE PT RECEIVED PLAVIX PRIOR AND AFTER THE PROCEDURE. THE PT "TOLERATED THE PROCEDURE WELL." NO COMPLICATIONS WERE REPORTED. THE PT PRESENTED 203 DAYS AFTER THE INITIAL PROCEDURE WITH AN 80% IN-STENT RESTENOSIS IN THE LAD. PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) WAS PERFORMED ON THE LESION USING A 2.5X15MM QUANTUM MAVERICK BALLOON. A 3.5X32MM NON-BOSTON SCIENTIFIC STENT WAS DEPLOYED AT 35MM IN THE LAD "INSIDE PREVIOUS THE TAXUS STENT." A 3.5X23MM NON-BOSTON SCIENTIFIC STENT WAS THEN DEPLOYED AT 32 ATM IN THE LAD "DISTAL TO FIRST STENT AND INSIDE THE PREVIOUS TAXUS STENT." A POST-INTERVENTION RESIDUAL STENOSIS OF 0% WAS REPORTED. THE PT 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 NIQ: STENT, CORONARY, DRUG ELUTING NIQ BOSTON SCIENTIFIC CORP. 3.0X32MM 8160995

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other| R .014 300CM HIGH TORQUE FLOPPY| 3MM J TIP 145CM GUIDEWIRE| .014 300 CM HIGH TORQUE FLOPPY