BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS (R) LIBERTÉ (R)

    MDR report key: 2142545 · Received June 28, 2011

    Report

    Report Number
    2134265-2011-02464
    Event Type
    Injury
    Date Received
    June 28, 2011
    Date of Event
    September 30, 2010
    Report Date
    May 31, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. PATIENT IDENTIFIER - (B)(4). 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    (B)(6) STUDY. IT WAS REPORTED THAT POST A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED ANGINA AND RESTENOSIS. THE TARGET LESION BEING TREATED WAS LOCATED IN THE SAPHENOUS VEIN GRAFT(SVG) OF THE MID RIGHT CORONARY ARTERY (RCA). THE LESION WAS 100% STENOSED, 3.0MM IN DIAMETER AND 20MM LONG. THE LESION WAS TREATED WITH PREDILATION AND PLACEMENT OF A 3.0X28MM TAXUS LIBERTE STENT. POST DILATION WAS PERFORMED. RESIDUAL STENOSIS WAS 5%. DURING THE INDEX PROCEDURE, AN UNKNOWN BARE METAL STENT WAS PLACED IN THE PROXIMAL SVG OF THE MID RCA. THE PATIENT WAS DISCHARGED 4 DAYS LATER ON ASPIRIN AND PRASUGREL. IN (B)(6) 2010, THE PATIENT WAS ADMITTED WITH UNSTABLE ANGINA. CARDIAC CATHETERIZATION WAS RECOMMENDED. IN (B)(6) 2010, CORONARY ANGIOGRAPHY REVEALED 100% DIFFUSE IN-STENT RESTENOSIS IN THE MID RCA OF THE PREVIOUSLY PLACED STENT. THE MID RCA WAS TREATED WITH CORONARY BYPASS GRAFT(CABG). RESIDUAL STENOSIS WAS 0%. THE EVENT WAS RESOLVED WITHOUT RESIDUAL EFFECT. THE PATIENT WAS DISCHARGED 4 DAYS LATER ON ASPIRIN AND PRASUGREL.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT POST A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED ANGINA AND RESTENOSIS. THE TARGET LESION BEING TREATED WAS LOCATED IN THE SAPPHEOUS VEIN GRAFT(SVG) OF THE MID RIGHT CORONARY ARTERY (RCA). THE LESION WAS 100% STENOSED, 3.0MM IN DIAMETER AND 20MM LONG. THE LESION WAS TREATED WITH PREDILATION AND PLACEMENT OF A 3.0X28MM TAXUS LIBERTE STENT. POST DILATION WAS PERFORMED. RESIDUAL STENOSIS WAS 5%. DURING THE INDEX PROCEDURE, AN UNKNOWN BARE METAL STENT WAS PLACED IN THE PROXIMAL SVG OF THE MID RCA. THE PATIENT WAS DISCHARGED 4 DAYS LATER ON ASPIRIN AND PRASUGREL. IN (B)(6) 2010, THE PATIENT WAS ADMITTED WITH UNSTABLE ANGINA. CARDIAC CATHETERIZATION WAS RECOMMENDED. IN (B)(6) 2010, CORONARY ANGIOGRAPHY REVEALED 100% DIFFUSE IN-STENT RESTENOSIS IN THE MID RCA OF THE PREVIOUSLY PLACED STENT. THE MID RCA WAS TREATED WITH CORONARY BYPASS GRAFT(CABG). RESIDUAL STENOSIS WAS 0%. THE EVENT WAS RESOLVED WITHOUT RESIDUAL EFFECT. THE PATIENT WAS DISCHARGED 4 DAYS LATER ON ASPIRIN AND PRASUGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS (R) LIBERTÉ (R) CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893628300 12916684

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention