BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 3890168 · Received June 24, 2014

    Report

    Report Number
    2134265-2014-03604
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    April 16, 2014
    Report Date
    May 28, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR.: THE COMPLAINT DEVICE WAS NOT RECEIVED 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

    SAME CASE AS MDR ID: 2134265-2014-03602, 2134265-2014-03601 AND 2134265-2014-03603. (B)(4) CLINICAL STUDY. IT WAS REPORTED THAT CHEST PAIN AND NON ST ELEVATION MYOCARDIAL INFARCTION (MI) OCCURRED. ON (B)(6) 2010, THE PATIENT PRESENTED WITH SEVERE INTERMITTENT CHEST PAIN AND WAS DIAGNOSED WITH INFERIOR ST-SEGMENT ELEVATION MI. CARDIAC CATHETERIZATION WAS RECOMMENDED. SUBSEQUENTLY, CORONARY ANGIOGRAPHY AND THE INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION WAS A DE NOVO LESION LOCATED IN THE DISTAL LEFT CIRCUMFLEX (LCX) WITH PRE-EXISTING THROMBUS, 100% STENOSIS, AND WAS 20 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0 MM. THE LESION WAS TREATED WITH THROMBECTOMY AND PRE-DILATATION FOLLOWED BY PLACEMENT OF A 3.00 X 24 MM TAXUS® LIBERTÉ® STENT. FOLLOWING POST-DILATION, RESIDUAL STENOSIS WAS 0%. THE TARGET LESION #2 WAS A DE NOVO LESION LOCATED IN THE PROXIMAL LCX WITH 70% STENOSIS AND WAS 16 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0 MM. TARGET LESION #2 WAS TREATED WITH DIRECT STENT PLACEMENT USING A 3.00 X 20 MM TAXUS® LIBERTÉ® STENT, RESULTING IN 0% RESIDUAL STENOSIS. TWO DAYS AFTER, THE PATIENT RETURNED TO THE CATHETERIZATION LAB FOR STAGED PROCEDURE ON THE LEFT ANTERIOR DESCENDING ARTERY (LAD). SUBSEQUENTLY, SELECTIVE CORONARY ANGIOGRAPHY WAS PERFORMED. THE TARGET LESION #3 WAS A DE NOVO LESION LOCATED IN THE MID LAD WITH 90% STENOSIS AND WAS 25 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0 MM. THE TARGET LESION #3 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.75 X 32 MM TAXUS® LIBERTÉ® STENT. FOLLOWING POST-DILATION, RESIDUAL STENOSIS WAS 0%. THE TARGET LESION #4 WAS A DE NOVO LESION LOCATED IN THE DISTAL LAD WITH 80% STENOSIS AND WAS 16 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75 MM. THE TARGET LESION #4 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.50 X 20 MM TAXUS® LIBERTÉ®. FOLLOWING POST-DILATION, RESIDUAL STENOSIS WAS 0%. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. ON (B)(6) 2014, THE PATIENT PRESENTED EMERGENTLY WITH ACUTE RETROSTERNAL CHEST PAIN AND BURNING SENSATION. AT THE TIME OF EVENT, THE PATIENT WAS ON PRASUGREL ONLY AND PATIENT STOPPED TAKING ASPIRIN ONE WEEK PRIOR TO THE EVENT. STUDY DRUG PER PROTOCOL WAS LAST TAKEN ON (B)(6) 2013. ELECTROCARDIOGRAM (ECG) WAS PERFORMED AND REVEALED SINUS RHYTHM WITH FUSION COMPLEXES. CARDIAC ENZYMES WERE NOTED TO BE ELEVATED BUT DID NOT MEET PROTOCOL DEFINITION OF MI. DUAL ANTIPLATELET WAS HELD AND WAS INSTRUCTED TO TAKE ASPIRIN ONLY. FIVE DAYS FROM THE ONSET OF SYMPTOMS, THE EVENT WERE CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED ON ASPIRIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367721 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893620250

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other