BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1172067 · Received September 23, 2008

    Report

    Report Number
    2134265-2008-02769
    Event Type
    Injury
    Date Received
    September 23, 2008
    Date of Event
    August 24, 2008
    Report Date
    August 27, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS. THE COMPLAINANT 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 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

    IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE PT EXPERIENCED ST ELEVATION, VF ARREST, AND ACUTE MYOCARDIAL INFARCTION (MI). THE PT PRESENTED EMERGENTLY WITH IN-STENT THROMBOSIS OF A PREVIOUSLY PLACED PROMUS DRUG ELUTING STENT. THERE WAS A 100% OCCLUSION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) AT THE SITE OF THE PREVIOUSLY PLACED 2.75X23MM STENT. THE PHYSICIAN ADVANCED AND INFLATED A 3X20MM MAVERICK BALLOON IN THE PROXIMAL LAD AT 12 ATMS FOR 18 SECONDS AND 14 ATMS FOR 18 SECONDS. THROMBECTOMY WAS PERFORMED ON THE THROMBUS. FOLLOWING THIS, THE PHYSICIAN IMPLANTED THE 3.00X24MM TAXUS EXPRESS2 DRUG ELUTING STENT IN THE PROXIMAL LAD AT 20 ATMS FOR 19 SECONDS. THE STENOSIS WAS REDUCED TO 0% FOLLOWING THE INTERVENTION, AND TIMI 3 FLOW WAS RESTORED. THE PROCEDURE WAS FINISHED WITHOUT COMPLICATIONS. MEDICATIONS USED DURING THE PROCEDURE INCLUDING PLAVIX, HEPARIN, AND NITROGLYCERINE. THE PT WAS ON CHRONIC PLAVIX AND ASPIRIN THERAPY. TWENTY DAYS LATER, THE PT EXPERIENCED VF ARREST AND AN ACUTE ST-ELEVATION MI AT HOME. HE WAS TAKEN TO THE HOSPITAL EMERGENTLY AND DEFIBRILLATED. THE PT WAS THEN PREPPED AND SENT FOR CORONARY INTERVENTION. THE PHYSICIAN ADVANCED A 3X20MM MAVERICK BALLOON AND INFLATED IT FOR 22 SECONDS AT 24 ATMS AND THEN AGAIN FOR 31 SECONDS AT 24 ATMS IN THE MID LAD. THE PHYSICIAN THEN IMPLANTED A 3.00X18MM PROMUS DRUG ELUTING STENT IN THE MID LAD AT 18 ATMS FOR 18 SECONDS. THEN, A PROMUS 3.50X8MM DRUG ELUTING STENT WAS IMPLANTED IN THE PROXIMAL LAD AT 14 ATMS FOR 38 SECONDS. AN INTRA AORTIC BALLOON PUMP WAS INSERTED. FOLLOWING THE INTERVENTION, THERE WAS 0% STENOSIS IN BOTH THE PROXIMAL AND MID LAD. THERE WERE NO PROCEDURAL COMPLICATIONS. MEDICATIONS GIVEN DURING THE PROCEDURE INCLUDED HEPARIN, REOPRO, AND NITROGLYCERINE. IT IS THOUGHT THAT THE PT MAY BE RESISTANT TO PLAVIX, AND HAS BEEN PLACED ON PLAYTOL INSTEAD.

    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 CORPORATION 3.00X24MM

    Patients

    Seq Age Sex Outcome Treatment
    1 WISEGUIDE 7FR GUIDE CATHETER| TRAVERSE GUIDE WIRE