BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 2925694 · Received January 22, 2013

    Report

    Report Number
    2134265-2013-00151
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 24, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. PATIENT IDENTIFIER: (B)(6). DEVICE EVALUATED BY MFR: 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).

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM, RELEVANT TESTS/LAB DATA: ADDITIONAL INFORMATION (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR#: 2134265-2013-00152. (B)(4). IT WAS REPORTED THAT POST A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY TREATMENT PROCEDURE, THE PATIENT EXPERIENCED SYMPTOMS OF ACUTE CORONARY SYNDROME. IN (B)(6) 2010, THE PATIENT PRESENTED WITH STABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE 80% STENOSED TARGET LESION WAS 20MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5MM AND LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS TREATED WITH PRE-DILATION AND PLACEMENT OF TWO OVERLAPPING STENTS; A 2.5X32MM TAXUS LIBERTE DISTALLY AND A 2.5X16MM TAXUS LIBERTE PROXIMALLY. FOLLOWING POST DILATION, RESIDUAL STENOSIS WAS 0%. THE NEXT DAY THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. IN (B)(6) 2012, A PROMUS ELEMENT STENT WAS IMPLANTED IN THE MID LAD TO TREAT 70-80% IN-STENT RESTENOSIS. IN (B)(6) 2012, THE PATIENT PRESENTED WITH CHEST PAIN AND WAS HOSPITALIZED. AT THE TIME OF THE EVENT, THE PATIENT WAS TAKING ASPIRIN AND OPEN LABEL PRASUGREL (NON STUDY DRUG). THE NEXT DAY, CORONARY ANGIOGRAPHY REVEALED 90% IN-STENT RESTENOSIS OF THE FIRST STENT IN THE LAD WHICH WAS TREATED WITH BALLOON ANGIOPLASTY RESULTING IN 0% RESIDUAL STENOSIS. ADDITIONALLY, THE 90% STENOSED FIRST OBTUSE MARGINAL WAS TREATED WITH DIRECT PLACEMENT OF A PROMUS DRUG ELUTING STENT WITH 0% RESIDUAL STENOSIS. THE NEXT DAY THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL.

    Description of Event or Problem · 1

    SAME CASE AS MFR#: 2134265-2013-00771, 2134265-2013-00152. SAME PATIENT AS MFR#: 2134265-2013-00939, 2134265-2013-00548. THE PREVIOUSLY NOTED "OCCLUDED UNKNOWN STENT DISTALLY" IN THE RCA, REVEALED DURING ANGIOGRAPHY IN (B)(6) 2012, WAS IDENTIFIED AS AN UNKNOWN PROMUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31388 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893632250 13456907

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention