BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1000414 · Received February 20, 2008

    Report

    Report Number
    2134265-2008-00477
    Event Type
    Injury
    Date Received
    February 20, 2008
    Date of Event
    January 20, 2005
    Report Date
    January 28, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME CASE MFR REPORT #2134265-2008-00475 AND #2134265-2008-00476. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE THROMBOSIS OCCURRED. THE PROCEDURE WAS EMERGENT DUE TO CHEST PAIN AND MYOCARDIAL INFARCTION (MI). A 2.5X20MM NON-BSC BALLOON CATHETER WAS USED TO PREDILATE THE PROXIMAL RIGHT CORONARY ARTERY (RCA), MID RCA AND POSTEROLATERAL BRANCH (PLB) OF THE RCA. A 2.5X20MM TAXUS EXPRESS2 DRUG ELUTING STENT (DES) WAS IMPLANTED IN THE PLB, A 3.0X28MM TAXUS EXPRESS2 DES WAS IMPLANTED IN THE RCA AND A 3.5X28MM TAXUS EXPRESS2 DES WAS IMPLANTED IN THE PROXIMAL RCA. ALL DEVICES SHOWED "GOOD ANGIOGRAPHIC RESULTS" WITH 0% STENOSIS. THE 40% LESION JUST BEFORE THE CRUX WAS DILATED TO 14 ATMOSPHERES (ATMS) WITH AN UNSPECIFIED BALLOON. SEVEN DAYS LATER, THE PATIENT HAD RECURRENT CHEST PAIN. A 2.75X20MM TAXUS EXPRESS2 DES WAS IMPLANTED IN THE DISTAL RCA AND A 2.5X12MM TAXUS EXPRESS2 DES WAS IMPLANTED IN PLB TO THE RCA. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE PATIENT WAS DISCHARGED ON LIPITOR 20MG DAILY, MAVIK 2MG DAILY, TOPROL XL 50MG DAILY, PLAVIX 75MG DAILY, ENTERIC COATED ASPIRIN 325MG DAILY AND ISORDIL 30MG DAILY. AT 259 DAYS LATER, THE PATIENT SUFFERED AN ACUTE INFERIOR-POSTERIOR MI AND THROMBOSIS WAS DISCOVERED IN THE PLB. A 2.5X15MM NON-BSC BALLOON CATHETER WAS USED TO TREAT THE THROMBOSIS. TIMI 3 FLOW WAS RESTORED. THE PT BECAME IMMEDIATELY BRADYCARDIC AND HYPERTENSIVE AND AN UNK TYPE TEMPORARY PACING WIRE WAS PLACED VIA THE FEMORAL VEIN APPROACH INTO THE RIGHT VENTRICLE. THE BRADYCARDIA RESOLVED. A 2.75X9MM NC MONORAIL BALLOON CATHETER WAS ALSO USED TO DILATE THE AREA OF THROMBOSIS. THERE WAS NO RESIDUAL STENOSIS PRESENT WITH TIMI 3 FLOW RESTORED. THE PT'S CHEST PAIN AND EKG CHANGES RESOLVED. THE PATIENT RECEIVED HEPARIN, REOPRO, NITROGLYCERIN, DURING THE PROCEDURE. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED. THE PATIENT'S CURRENT CONDITION IS UNK.

    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 2.5X12MM

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other| R