BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1021118 · Received March 27, 2008

    Report

    Report Number
    2134265-2008-00895
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    March 9, 2008
    Report Date
    March 10, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE WOULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PROD 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 #2134265-2008-00893. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE THROMBOSIS AND VESSEL SPASM REQUIRING SURGERY OCCURRED. THE TARGET LESION WAS IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE TARGET LESION WAS NOT PREDILATED. THE PT HAD A 2.75X32MM TAXUS EXPRESS2 DRUG ELUTING STENT (DES) AND A 3.0X12MM TAXUS EXPRESS2 DES IMPLANTED IN THE LAD TO TREAT THE TARGET LESION. THE DEVICES OVERLAP AND WERE CONSIDERED TO BE WELL POSITIONED AND WELL APPOSED. THE PT WAS GIVEN INTEGRILIN DURING THE PROCEDURE. THERE WERE NO PT COMPLICATIONS AND THE PT WAS DISCHARGED THE FOLLOWING DAY. TWO DAYS FOLLOWING DISCHARGE, THE PT EXPERIENCED CHEST PAIN FOR 1-2 HRS AND RETURNED TO THE FACILITY WHERE THROMBOSIS WAS DISCOVERED INSIDE THE 2 PREVIOUSLY IMPLANTED TAXUS EXPRESS2 DES. THE PT HAD BEEN TAKING PLAVIX AS PRESCRIBED. A 3.0X20MM NON-BSC BALLOON CATHETER WAS USED TO RESTORE BLOOD FLOW IN THE LAD. THERE WERE NO ADD'L PT COMPLICATIONS WITH THE PT'S CONDITION REPORTED AS "GOOD". THE FOLLOWING MORNING, THE PT'S TROPONINS WERE FOUND TO BE "ELEVATED" AND THE PT WAS RE-CATHED. IT WAS DISCOVERED THAT THE PREVIOUSLY IMPLANTED TAXUS EXPRESS2 DES WERE OPEN; HOWEVER, VESSEL SPASM HAD OCCURRED IN THE DISTAL LAD. NO ATTEMPTS TO TREAT THE VESSEL SPASM WERE PERFORMED AS THE PHYSICIAN FELT THAT SURGERY WAS THE BEST TREATMENT CHOICE FOR THE PT. THE PT HAD SINGLE GRAFT CORONARY ARTERY SURGERY TO THE LAD THE FOLLOWING DAY. THE PT HAS REPORTEDLY HAD A "GOOD OUTCOME" FOLLOWING SURGERY.

    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 11224160

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other