BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2822691 · Received November 7, 2012

    Report

    Report Number
    2134265-2012-06820
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    October 11, 2011
    Report Date
    October 9, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. (B)(6). DEVICE EVALUATION 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 POST A STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED CHEST PAINS AND TARGET VESSEL REVASCULARIZATION WAS PERFORMED. IN (B)(6) 2008, THE PATIENT PRESENTED WITH CHEST DISCOMFORT DESCRIBED AS "BAD CASE OF INDIGESTION" OCCURRING BOTH AT REST AND ON EXERTION ASSOCIATED WITH NAUSEA AND BACK PAIN. STRESS ECHOCARDIOGRAM WAS ABNORMAL WITH REPRODUCTION OF SYMPTOMS WITH EXERCISE, ASSOCIATED WITH PAROXYSMAL ATRIAL FIBRILLATION EPISODES WITH RIGHT BUNDLE BRANCH BLOCK. THE PATIENT WAS DIAGNOSED WITH UNSTABLE ANGINA AND CARDIAC CATHETERIZATION WAS RECOMMENDED. THE 80% STENOSED AND 10MM LONG TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX ARTERY WITH A REFERENCE VESSEL DIAMETER OF 4.0MM. THE TARGET LESION WAS TREATED WITH PRE-DILATION AND PLACEMENT OF A 4.00X16MM TAXUS EXPRESS2 STENT, RESULTING IN 0% RESIDUAL STENOSIS. IN ADDITION A NON TARGET LESION WITH 80% STENOSIS LOCATED IN THE MIDDLE LEFT ANTERIOR DESCENDING ARTERY WAS TREATED WITH PRE-DILATION AND PLACEMENT OF A 3.00X20MM TAXUS LIBERTE STENT, RESULTING IN 0% RESIDUAL STENOSIS. THE FOLLOWING DAY THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2011, DURING A FOLLOW UP VISIT, THE PATIENT REPORTED OF COMPLAINTS OF CHEST DISCOMFORT RADIATING TO THE RIGHT ARM. CARDIAC CATHETERIZATION WAS SCHEDULED. IT WAS NOTED THAT THE PATIENT HAD VARIABILITY IN ST SEGMENTS AND ELEVATED TROPONIN. THE PATIENT WAS HOSPITALIZED THE SAME DAY. THE 99% STENOSED TARGET LESION WAS LOCATED IN 1ST OBTUSE MARGINAL AND WAS TREATED WITH DIRECT STENT PLACEMENT USING A 3.50X12 MM NON BSC BARE METAL STENT, RESULTING IN 0% RESIDUAL STENOSIS. THE FOLLOWING DAY THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED.

    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 H7493800116400 0009641808

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention