BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1040084 · Received May 7, 2008

    Report

    Report Number
    2134265-2008-01320
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    April 14, 2008
    Report Date
    April 17, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 COULD 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 #2134265-2008-01319. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE,LATE STENT THROMBOSIS OCCURRED. THE PROCEDURE WAS INDICATED DUE TO NON-Q WAVE MYOCARDIAL INFARCTION (MI). THE TARGET LESIONS WERE IN THE PROXIMAL AND MID PORTIONS OF THE RIGHT CORONARY ARTERY (RCA). THE VESSEL SIZE WAS 3.5 MM. A 2.25 X 20 MM MAVERICK BALLOON WAS USED TO PREDILATE THE MID RCA INFLATED TO 6 ATMOSPHERES (ATMS) FOR 45 SECONDS (SECS), 6 ATMS FOR 35 SECS AND 11 ATMS FOR 35 SECS. A 2.5 X 24 MM TAXUS EXPRESS2 DRUG ELUTING STENT (DES) WAS IMPLANTED IN THE MID RCA DEPLOYED AT 8 ATMS FOR 35 SECS. THE STENT DELIVERY BALLOON WAS USED TO PREDILATE THE PROXIMAL RCA AT 12 ATMS FOR 30 SECS. A 2.5 X 24 MM TAXUS EXPRESS2 DES WAS IMPLANTED IN THE PROXIMAL RCA OVERLAPPING THE PREVIOUSLY IMPLANTED 2.5 X 24 MM TAXUS EXPRESS2 DES DEPLOYED AT 9 ATMS FOR 35 SECS. A 2.75 X 13 MM NON-BSC BALLOON CATHETER WAS USED TO POST DILATE THE MID AND PROXIMAL RCA INFLATED MULTIPLE TIMES FROM 7-10 ATMS FOR 30 SECS EACH INFLATION. THE PT WAS GIVEN HEPARIN, FENTANYL, ANGIOMAX, NITRO, PLAVIX, ANCEF, OPTIRAY, LIDOCAINE, AND PHENERGAN DURING THE PROCEDURE. THE PT WAS PRESCRIBED 325 MG ASPIRIN AND 75 MG PLAVIX FOR FOLLOW-UP. THERE WERE NO COMPLICATIONS REPORTED. AT 172 DAYS LATER, THE PT EXPERIENCED AN ACUTE MI WITH THROMBOSIS DISCOVERED IN BOTH TAXUS EXPRESS2 DES. IT WAS REPORTED THAT THE PT HAD DISCONTINUED TAKING PLAVIX ON AN UNK DATE DUE TO COST. THE THROMBOSIS WAS TREATED WITH AN UNK TYPE NON-COMPLIANT BALLOON. THERE WERE NO ADD'L PT COMPLICATIONS REPORTED WITH THE PT "DOING WELL." THE PT HAS BEEN SCHEDULED FOR ANOTHER "PROCEDURE" NOT RELATED TO THE THROMBOSIS EVENT.

    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 2.5X24MM

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 2.75X13MM POWERSAIL BALLOON CATHETER