BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1760292 · Received July 16, 2010

    Report

    Report Number
    2134265-2010-01852
    Event Type
    Injury
    Date Received
    July 16, 2010
    Date of Event
    September 19, 2008
    Report Date
    September 19, 2008
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE BATCH NUMBER IS UNKNOWN. THEREFORE A REVIEW OF THE MANUFACTURING DOCUMENTATION COULD NOT BE PERFORMED. THE MOST PROBABLE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATION AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED IN THE DIRECTION FOR USE (DFU). (B)(4).

    Description of Event or Problem · 1

    (B)(4) CLINICAL STUDY. SAME CASE AS 2134265-2010-00504. IT WAS REPORTED THAT FOLLOWING A CORONARY DRUG-ELUTING STENTING TREATMENT PROCEDURE THE PATIENT PRESENTED WITH IN-STENT RESTENOSIS. THE PATIENT PRESENTED IN THE EMERGENCY ROOM WITH CHEST PAIN IN (B)(6) 2007. ANGIOGRAPHY REVEALED AN 80% IN-STENT RESTENOSIS OF A NON-BSC BARE METAL STENT THAT WAS PREVIOUSLY IMPLANTED IN (B)(6) 2006 IN THE PROXIMAL AND MID RIGHT CORONARY ARTERY (RCA). THE PATIENT UNDERWENT REVASCULARIZATION CONSISTING OF PRE-DILATATION WITH A 3.75X10MM ULTRA2 MONORAIL CUTTING BALLOON, WHICH WAS INFLATED 5 TIMES TO 10 ATMOSPHERES (ATMS) FOR 60 SECONDS EACH RESULTING IN 30% RESIDUAL STENOSIS. A 3.5X32MM TAXUS EXPRESS2 NON STUDY STENT WAS THEN DEPLOYED IN THE MID RCA AT 16 ATMS FOR 30 SECONDS. AN ATTEMPT WAS MADE TO PLACE A SECOND 3.5X32MM TAXUS EXPRESS2 STENT, BUT IT COULD NOT CROSS THE EDGE OF THE STENT JUST IMPLANTED. POST-DILATATION OF THE IMPLANTED STENT WAS THEN PERFORMED WITH A NON-BSC 3.5MM BALLOON AT 20 ATMS FOR 30 SECONDS RESULTING IN 0% RESIDUAL STENOSIS. THE HEAVY WEIGHT GUIDE WIRE WAS THEN EXCHANGED FOR A MORE FLEXIBLE GUIDE WIRE AND THE SECOND 3.5X32MM TAXUS EXPRESS2 STENT WAS AGAIN ADVANCED AND SUCCESSFULLY DEPLOYED AT 16 ATMS FOR 30 SECONDS OVERLAPPING THE FIRST EVENT, GOING BACK TO THE OSTIUM IN THE RCA. IVUS WAS PERFORMED CONFIRMING THE STENTS WERE WELL APPOSED AND WELL EXPANDED RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND PLAVIX. IN (B)(6) 2008, THE PATIENT AGAIN PRESENTED WITH UNSTABLE ANGINA. ANGIOGRAPHY REVEALED AN 80% RESTENOSIS OF THE TAXUS EXPRESS2 STENT LOCATED IN THE PROXIMAL RCA. A NON-BSC DRUG-ELUTING STENT WAS IMPLANTED RESULTING IN 0% RESIDUAL STENOSIS AND TIMI 3 FLOW. THE PATIENT WAS DISCHARGED THE NEXT DAY WITH NO RESIDUAL EFFECTS.

    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 - MAPLE GROVE UNK432

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention