BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 2902084 · Received January 8, 2013

    Report

    Report Number
    2134265-2012-08184
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 10, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. (B)(4). DEVICE EVALUATION 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). IT WAS REPORTED THAT POST A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, THE PATIENT EXPERIENCED IN-STENT RESTENOSIS. IN (B)(6) 2010, THE PATIENT WAS REFERRED FOR PERCUTANEOUS CORONARY INTERVENTION. THE 99% STENOSED AND 16MM LONG TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX ARTERY WITH A REFERENCE VESSEL DIAMETER OF 3.00MM. THE TARGET LESION WAS TREATED WITH PRE-DILATION AND PLACEMENT OF A 3.00X16MM TAXUS LIBERTE STENT RESULTING IN 0% RESIDUAL STENOSIS FOLLOWING POST DILATION. THE FOLLOWING DAY THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. IN (B)(6) 2010, THE PATIENT RETURNED TO THE CATH LAB FOR A STAGED PROCEDURE. THE 70% STENOSED AND 50MM LONG SECOND TARGET LESION WAS LOCATED IN THE MID TO DISTAL RIGHT CORONARY ARTERY WITH A REFERENCE VESSEL DIAMETER OF 3.00 MM. THE SECOND TARGET LESION WAS TREATED WITH PRE-DILATION AND PLACEMENT OF A 3.00X38MM TAXUS LIBERTE STENT OVERLAPPING A 3.50X20MM TAXUS LIBERTE STENT RESULTING IN 0% STENOSIS FOLLOWING POST DILATION. THE PATIENT WAS DISCHARGED THE SAME DAY ON ASPIRIN AND PRASUGREL. IN (B)(6) 2012, THE PATIENT PRESENTED WITH CHEST PAIN AND 2 WEEKS OF PROGRESSIVE DYSPNEA ON EXERTION. THE PATIENT WAS DIAGNOSED WITH UNSTABLE ANGINA AND CARDIAC CATHETERIZATION WAS RECOMMENDED. THE PATIENT HAD FAIRLY MARKED DYNAMIC ANTERIOR AND ANTEROLATERAL ST DEPRESSIONS. TROPONIN WAS SLIGHTLY ELEVATED AT 0.33 NG/ML; HOWEVER, THE CK-MB LEVEL REMAINED NORMAL. A 99% PROXIMAL EDGE IN-STENT RESTENOSIS OF THE STUDY STENT IN PROXIMAL LEFT CIRCUMFLEX WAS NOTED AND WAS TREATED WITH CUTTING BALLOON ANGIOPLASTY AND PLACEMENT OF 3.00X8 MM PROMUS DRUG ELUTING STENT, RESULTING IN 0% RESIDUAL STENOSIS. THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS. THE FOLLOWING DAY THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8741 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893616300 0013258510

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention