BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2831747 · Received November 14, 2012

    Report

    Report Number
    2134265-2012-07053
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    February 3, 2012
    Report Date
    October 16, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MANUFACTURER - IT IS 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. (B)(4).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT POST A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT UNDERWENT INTERVENTION. IN (B)(6) 2008, THE PATIENT PRESENTED WITH RECURRENT CHEST PAIN. THE PATIENT WAS DIAGNOSED WITH STABLE ANGINA (CCS CLASS: 2) AND CARDIAC CATHETERIZATION WAS RECOMMENDED. THE TARGET LESION BEING TREATED WAS LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX (CX). THE LESION WAS 95% STENOSED, 3.5MM IN DIAMETER AND 10MM LONG. THE LESION WAS TREATED WITH PREDILATION AND PLACEMENT OF A 3.5X16MM STUDY STENT. POST DILATION WAS PERFORMED. RESIDUAL STENOSIS WAS 9%. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2012, THE PATIENT PRESENTED WITH EXERTIONAL CHEST PAIN STARTING APPROXIMATELY 3 WEEKS AGO. THE PATIENT WAS DIAGNOSED WITH ANGINA CLASS 3. ELECTROCARDIOGRAM WAS NEGATIVE AND NUCLEAR STRESS TEST REVEALED NO ISCHEMIC CHANGES. CARDIAC CATHETERIZATION WAS RECOMMENDED. PERCUTANEOUS CORONARY INTERVENTION WAS ATTEMPTED TO OPEN THE CHRONIC TOTAL OCCLUSION IN THE ATRIOVENTRICULAR CIRCUMFLEX. DURING THE INTERVENTION, PROLONGED ATTEMPTS WERE MADE TO CROSS THE TOTAL OCCLUSION IN AV CIRCUMFLEX, BY GRADUALLY INCREASING THE WEIGHT OF WIRES INCLUDING LUGE WIRE, CHOICE INTERMEDIATE WIRE AND CHOICE STANDARD WIRE. HOWEVER THE ATTEMPTS WERE UNSUCCESSFUL. THE PROCEDURE WAS STOPPED WITH NO COMPLICATIONS. THE EVENT WAS CONSIDERED TO BE RESOLVED WITH RESIDUAL EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE UNK432 9715384

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention