BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ® ATOM¿

    MDR report key: 3111333 · Received May 14, 2013

    Report

    Report Number
    2134265-2013-03512
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    December 8, 2012
    Report Date
    April 15, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6). DEVICE IS COMBINATION PRODUCT. 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)(6) CLINICAL STUDY. SAME CASE AS MDR ID# 2134265-2013-00859. SAME CASE AS MDR ID# 2134265-2013-00860. SAME CASE AS MDR ID# 2134265-2013-00852. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, IN-STENT RESTENOSIS AND A MYOCARDIAL INFARCTION OCCURRED. (B)(6) 2010 A 5 X 2.25MM, 90% STENOSED LESION IN THE 1ST DIAGONAL WAS TREATED WITH CUTTING BALLOON ANGIOPLASTY AND THE PLACEMENT OF A 2.25 X 8MM TAXUS LIBERTE ATOM WITH 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. (B)(6) 2012 - THE PATIENT PRESENTED WITH PERSISTENT CHEST DISCOMFORT AND WAS HOSPITALIZED ON SAME DAY. ECG REVEALED MARKED ST ABNORMALITY POSSIBLE INFERIOR SUBENDOCARDIAL INJURY. CARDIAC ENZYMES WERE ELEVATED CONSISTENT WITH THE PROTOCOL DEFINITION OF MI. THE PATIENT WAS DIAGNOSED WITH A NON ST ELEVATION MYOCARDIAL INFARCTION. THE PATIENT WAS TAKING ASPIRIN ONLY; THE STUDY DRUG WAS LAST TAKEN IN (B)(6) 2011. THE 90% STENOSIS LOCATED IN THE 1ST DIAGONAL WAS TREATED WITH PRE-DILATATION AND PLACEMENT 2.5 X 8MM ION STENT. RESIDUAL STENOSIS WAS 0%, WITH TIMI III FLOW. IN ADDITION, 90% STENOSIS IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF 2.50 X 8MM ION STENT. FOLLOWING STENT DEPLOYMENT SLOW FLOW IN THE LAD, DISTAL TO THE STENT, WAS NOTED. THIS WAS TREATED WITH ADMINISTRATION OF NITROGLYCERIN-INDUCED CORONARY VASODILATATION (NTG IC) WITH MINIMAL IMPROVEMENT. THE STENT WAS POST DILATED USING A 2.0 X 8 MM EMERGE BALLOON, FOLLOWING POST DILATATION ANOTHER 2.25 X 16 MM ION STENT WAS DEPLOYED DISTAL TO THE PROXIMAL LAD STENT, HOWEVER, NO IMPROVEMENT IN FLOW WAS NOTED EVEN AFTER ADMINISTRATION OF NTG IC. THE PROCEDURE WAS ENDED WITH 0% RESIDUAL STENOSIS AND TIMI I FLOW TO LAD. ANGIOGRAPHY WAS PERFORMED AND REVEALED A FILLING DEFECT IN THE PROXIMAL AND MID LAD. THEREFORE, AN ASPIRATION THROMBECTOMY WAS PERFORMED; HOWEVER, THERE WAS MINIMAL IMPROVEMENT. THE PATIENT SUBSEQUENTLY HAD CARDIOGENIC SHOCK AND DEPRESSED LEFT VENTRICULAR FUNCTION. ISCHEMIC ECG CHANGES WERE NOTED IN THE ANTERIOR LEADS. BASED ON REVIEW OF ANGIOGRAM IMAGES, THE PHYSICIAN ELECTED TO TREAT THE PATIENT MEDICALLY. THE EVENT IS CONSIDERED RESOLVING/ RECOVERING. THE PATIENT WAS DISCHARGED NINE DAYS LATER ON ASPIRIN AND EFFIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212411 TAXUS® LIBERTÉ® ATOM¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H749389368220 12768753

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention