BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ® ATOM¿

    MDR report key: 2981638 · Received February 27, 2013

    Report

    Report Number
    2134265-2013-01037
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    November 22, 2011
    Report Date
    January 29, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT AFTER A PERCUTANEOUS CORONARY INTERVENTION (PCI) STENTING TREATMENT PROCEDURE THE PATIENT EXPERIENCED MYOCARDIAL INFARCTION. THE SUBJECT PRESENTED WITH UNSTABLE ANGINA (BRAUNWALD CLASSIFICATION: IB) AND CARDIAC CATHETERIZATION WAS RECOMMENDED. THE TARGET LESION #1 WAS LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 90% STENOSIS AND WAS 14 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.2 MM. THE TARGET LESION #1 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.25 X 16 MM TAXUS ATOM STENT, WITH 0% RESIDUAL STENOSIS. THE SUBJECT WAS DISCHARGED THE FOLLOWING DAY ON ASPIRIN AND PRASUGREL. IN (B)(6) 2011, THE SUBJECT WAS HOSPITALIZED FOR EXPLORATION AND ATTEMPTED RESECTION OF PANCREATIC TUMOR. POST PROCEDURE, THE TUMOR WAS FOUND TO BE UNRESECTABLE. THE FOLLOWING DAY THE SUBJECT DEVELOPED 4-BEAT NONSUSTAINED VENTRICULAR TACHYCARDIA. ECG CHANGES INDICATED POSSIBLE ISCHEMIA. CARDIAC ENZYMES WERE FOUND TO BE ELEVATED AND THE SUBJECT WAS DIAGNOSED WITH NON-Q WAVE MYOCARDIAL INFARCTION. AT THE TIME OF THE EVENT, THE SUBJECT WAS TAKING ASPIRIN AND STUDY MEDICATION. DUE TO RECENT SURGERY, CARDIAC CATHETERIZATION WAS NOT RECOMMENDED. THE SUBJECT HAD NO COMPLAINTS OF CHEST PAIN AND NO SPECIFIC TREATMENT WAS GIVEN. THREE DAYS LATER THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE SUBJECT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83371 TAXUS® LIBERTÉ® ATOM¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893716220 13435556

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other