BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 3193190 · Received June 27, 2013

    Report

    Report Number
    2134265-2013-04486
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 31, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS A COMBINATION PRODUCT. THE 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

    (B)(4) CLINICAL TRIAL. SAME CASE AS MDR ID: 2134265-2013-04487. IT WAS REPORTED THAT POST PERCUTANEOUS CORONARY INTERVENTION PROCEDURE IN-STENT RESTENOSIS OCCURRED. IN (B)(6) 2010, THE SUBJECT PRESENTED WITH CHEST PAIN ASSOCIATED WITH DIAPHORESIS AND NAUSEA. THE SUBJECT WAS DIAGNOSED WITH NON Q-WAVE NON ST ELEVATION MYOCARDIAL INFARCTION (KILLIP CLASSIFICATION: I) AND CARDIAC CATHETERIZATION WAS RECOMMENDED. THE INDEX PROCEDURE WAS PERFORMED AND THE SUBJECT WAS ENROLLED IN THE TAXUS LIBERTE STUDY. TARGET LESION #1 WAS A DE-NOVO LESION LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY WITH 90% STENOSIS AND WAS 20 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.50 MM. TARGET LESION #1 WAS TREATED WITH PRE-DILATATION FOLLOWED BY PLACEMENT OF A 2.50 X 28 MM TAXUS LIBERTE STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. THE NEXT DAY, THROMBECTOMY WAS PERFORMED AND A 2.50 X 12 MM TAXUS LIBERTE STENT WAS PLACED IN OVERLAPPING FASHION WITH THE PREVIOUSLY PLACED STUDY STENT IN DISTAL LEFT ANTERIOR DESCENDING ARTERY. FOLLOWING POST-DILATATION, THERE WAS EXCELLENT ANGIOGRAPHIC RESULT WITH NO EVIDENCE OF RESIDUAL STENOSIS. THE SUBJECT WAS DISCHARGED ON ASPIRIN AND PRASUGREL AFTER TWO DAYS. IN (B)(6) 2013, THE SUBJECT PRESENTED WITH LEFT ANTERIOR CHEST PAIN RADIATING TO THE LEFT ARM ASSOCIATED WITH NAUSEA AND DIAPHORESIS. CORONARY ANGIOGRAPHY REVEALED, LAD: 50-60% MID VESSEL STENOSIS INCLUDING AN AREA OF IN-STENT RESTENOSIS FROM PREVIOUSLY PLACED STENT. IN (B)(6) 2013, THE EVENT OF IN-STENT RESTENOSIS OF LEFT ANTERIOR DESCENDING ARTERY WAS CONSIDERED TO BE RESOLVED WITH RESIDUAL EFFECTS. THE SUBJECT WAS DISCHARGED ON THE SAME DAY ON ASPIRIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293848 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493893628250 13358101

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention