BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1080946 · Received July 23, 2008

    Report

    Report Number
    2134265-2008-02073
    Event Type
    Injury
    Date Received
    July 23, 2008
    Report Date
    June 26, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 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

    IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, A STENT THROMBOSIS OCCURRED. THE PT PRESENTED WITH CRUSHING SEVERE SUBSTERNAL CHEST PAIN AND WAS GIVEN NITROGLYCERIN. THE 90% STENOSED LESION BEING TREATED WAS LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS PREDILATED WITH AN UNK 2.5X15MM BALLOON, INFLATED TO 8ATM, WITH IMPROVED ANGIOGRAPHIC RESULTS. A 2.75X28MM TAXUS EXPRESS2 DRUG ELUTING STENT WAS DEPLOYED AT 14 ATM. THE STENT WAS POST DILATED WITH A 2.75X8MM QUANTUM BALLOON, DUE TO A SLIGHT AREA OF UNDER-EXPANSION TOWARD THE DISTAL END OF THE STENT, INFLATED TO 18 ATM. REPEAT ANGIOGRAPHY SHOWED NO RESIDUAL STENOSIS, BRISK DISTAL FLOW AND NO EVIDENCE OF DISSECTION. THE PT WAS MARKEDLY HYPERTENSIVE AND TACHYCARDIC DURING THE PROCEDURE REQUIRING SEVERAL DOSES OF BETA BLOCKERS. HEPARIN AND INTEGRILIN WERE GIVEN. THE PT TOLERATED THE PROCEDURE WELL. SIX DAYS POST THE STENT PLACEMENT, THE PT PRESENTED WITH BACK PAIN. SIXTEEN DAYS POST THE INITIAL PROCEDURE, THE PT PRESENTED WITH CHEST PAIN. CHEST X-RAY IDENTIFIED SMALL BANDS OF ATHELECTASIS/SCARRING IN THE LINGUAL AND RIGHT MIDDLE LOBE, BUT NO ACTIVE PULMONARY DISEASE. NINETEEN DAYS LATER, THE PT WAS EXPERIENCING COUGHING AND SPITTING UP BLOOD. CHEST X-RAY IDENTIFIED SMALL BANDS OF ATHELECTASIS/SCARRING IN THE LINGUAL AND RIGHT MIDDLE LOBE. HEART AND PULMONARY VASCULARITY ARE NORMAL. THE THORACIC AORTA IS ARTERIOSCLEROTIC, BUT NOT DILATED. NO ACTIVE INFILTRATES, MASSES OR PLEURAL EFFUSION ARE SEEN. TWO YEARS AND NINE MONTHS POST THE STENT PLACEMENT, THE PT PRESENTED WITH EPISODES OF CHEST DISCOMFORT. A RECENT STRESS TEST SHOWED INFERIOR ISCHEMIA. ANGIOGRAPHY SHOWED THERE WERE NO HIGH-GRADE CORONARY LESIONS TO WARRANT INTERVENTIONS. THE PT EXPERIENCED 'LATE' STENT THROMBOSIS. THE DATE AND DETAILS OF THE EVENT ARE NOT KNOWN AT THIS TIME.

    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 2.75X28 MM

    Patients

    Seq Age Sex Outcome Treatment
    1 Other