BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS (R) LIBERTÉ (R) ATOM (TM)

    MDR report key: 1983920 · Received February 10, 2011

    Report

    Report Number
    2134265-2011-00294
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 12, 2011
    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)(4).

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6). DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT 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

    IT WAS FURTHER REPORTED THAT TARGET LESION 1 WAS LOCATED IN THE RIGHT POSTERIOR DESCENDING ARTERY, NOT THE RIGHT CORONARY ARTERY AS PREVIOUSLY REPORTED. IN (B)(6) 2011 THE PATIENT PRESENTED WITH CHEST PAIN. THE ECG WAS NORMAL WITH NON-SPECIFIC ST ABNORMALITY AND WAS NOTED NEGATIVE FOR CARDIAC ENZYMES. 250 DAYS POST INDEX PROCEDURE THE INSTENT RESTENOSIS WAS TREATED WITH A DIRECT STENT PLACEMENT USING A 2.50X12MM DRUG ELUTING PROMUS STENT.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE IN-STENT RESTENOSIS OCCURRED. IN MAY 2010 TARGET LESION #1 WAS LOCATED IN THE MID RIGHT CORONARY ARTERY WITH 70% STENOSIS AND WAS 10MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25MM. THE LESION WAS TREATED WITH DIRECT STENT PLACEMENT OF A 2.25MMX12MM TAXUS LIBERTE STENT. FOLLOWING POST DILATATION RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND PRASUGREL. IN (B)(6) 2011 CORONARY ANGIOGRAPHY REVEALED 70-80% IN-STENT RESTENOSIS OF THE TAXUS LIBERTE STENT PLACED IN THE RIGHT CORONARY ARTERY. THIS WAS TREATED WITH AN ANGIOPLASTY BALLOON AND A DRUG ELUTING STENT. RESIDUAL STENOSIS WAS 0% AND TIMI FLOW WAS 3. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND PRASUGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS (R) LIBERTÉ (R) ATOM (TM) CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893612220 0013084199

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention