BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS? ELEMENT?

    MDR report key: 3132130 · Received May 29, 2013

    Report

    Report Number
    2134265-2013-03574
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    December 18, 2012
    Report Date
    May 2, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: 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 SUBSEQUENT TO A STENTING TREATMENT PROCEDURE THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION AND IN-STENT RESTENOSIS OCCURRED. THE PATIENT PRESENTED WITH CLASS 4 STABLE ANGINA IN (B)(6) 2011 AND UNDERWENT A CARDIAC CATHETERIZATION PROCEDURE WHICH REVEALED 1 TARGET LESION. THE 70% STENOSED LESION LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) WITH A REFERENCE VESSEL DIAMETER OF 3.00MM AND A LESION LENGTH OF 2MM. THE LESION WAS PREDILATED WITH AN UNSPECIFIED BALLOON AND 3.00X12MM TAXUS ELEMENT STENT WAS DEPLOYED, RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED 2 DAYS LATER ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2012 THE PATIENT WAS ADMITTED TO THE HOSPITAL AND HAD BEEN EXPERIENCING THE SENSATION OF PRESSURE AND BURNING IN THE CHEST AND DIZZINESS OVER THE PAST 2 MONTHS. LAB ENZYMES WERE INVESTIGATED AND ELEVATED CARDIAC ENZYME VALUE WAS OBSERVED AND AN EVENT OF MYOCARDIAL INFARCTION WAS REPORTED (PEAK TROPONIN T=0.016 NG/ML, ULN= 0.014 NG/ML). CARDIAC CATHETERIZATION WAS PERFORMED REVEALING 30% PROXIMAL RESTENOSIS IN THE RCA. ECG WAS PERFORMED AND NO ISCHEMIC SYMPTOMS WERE OBSERVED. MEDICATION WAS GIVEN TO TREAT THE EVENT AND THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS ON THE FOLLOWING DAY. TWO DAYS AFTER BEING ADMITTED TO THE HOSPITAL THE PATIENT WAS DISCHARGED ON ASPIRIN. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234863 TAXUS? ELEMENT? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493902512300 12953002

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention