BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 2801078 · Received October 23, 2012

    Report

    Report Number
    2134265-2012-06335
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    September 21, 2012
    Report Date
    September 24, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    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. (B)(6). DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    (B)(4). SAME CASE AS: 2134265-2012-06340, 2134265-2012-06341. IT WAS REPORTED THAT POST A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED WORSENING CORONARY ARTERY DISEASE AND RESTENOSIS. LESION 1 WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). THE LESION WAS 70% STENOSED, 3.7MM IN DIAMETER AND 16MM LONG. THE LESION WAS TREATED WITH PREDILATION AND PLACEMENT OF A 3.5X32MM TAXUS LIBERTE STENT. RESIDUAL STENOSIS WAS 0%. LESION 2 WAS AN IN-STENT RESTENOTIC LESION, LOCATED IN THE PROXIMAL RCA. THE LESION WAS 85% STENOSED, 3.7MM IN DIAMETER AND 32MM LONG. THE LESION WAS TREATED WITH PREDILATION AND PLACEMENT OF A 3.5X16MM TAXUS LIBERTE STENT. RESIDUAL STENOSIS WAS 0%. LESION 3 WAS LOCATED IN THE DISTAL RCA. THE LESION WAS 70% STENOSED, 3.5MM IN DIAMETER AND 18MM LONG. THE LESION WAS TREATED WITH PREDILATION AND PLACEMENT OF A 3.5X12MM TAXUS LIBERTE STENT. POST DILATION WAS PERFORMED. RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. IN (B)(6) 2012, THE PATIENT WAS DIAGNOSED WITH WORSENING CORONARY ARTERY DISEASE AND CARDIAC CATHETERIZATION WAS RECOMMENDED. THE 60-70% IN-STENT RESTENOSIS OF THE PREVIOUSLY DEPLOYED STUDY STENTS FROM MID TO DISTAL RCA WAS TREATED WITH PLACEMENT OF A 3.5X30MM NON-BSC STENT. POST DILATION WAS PERFORMED. RESIDUAL STENOSIS WAS 0%. IN ADDITION, THE 70-75% IN-STENT RESTENOSIS OF THE PREVIOUSLY DEPLOYED STENT IN THE DISTAL CIRCUMFLEX WAS TREATED WITH THE PLACEMENT OF A 2.25X27MM NON-BSC STENT. POST DILATION WAS PERFORMED. RESIDUAL STENOSIS WAS 0%. THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493893632350 12562927

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention