BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ® ATOM¿

    MDR report key: 2863076 · Received December 10, 2012

    Report

    Report Number
    2134265-2012-07486
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    December 20, 2011
    Report Date
    November 13, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 PATIENT AS MDR ID# 2134265-2012-07454, AND 2134265-2012-08101. IT WAS REPORTED THAT POST CORONARY STENTING TREATMENT PROCEDURE, IN-STENT RESTENOSIS, ANGINA, AND SPASM OCCURRED. IN (B)(6) 2002 A NIR STENT WAS IMPLANTED IN THE OSTIAL RIGHT CORONARY ARTERY (RCA) IN (B)(6) 2003, IN-STENT RESTENOSIS OF A NON-BSC STENT WAS PRESENT IN THE LEFT INTERNAL MAMMARY ARTERY (LIMA) TO LEFT ANTERIOR DESCENDING ARTERY (LAD) AND WAS TREATED WITH CUTTING BALLOON TECHNIQUE. IN ADDITION, THE IN-STENT RESTENOSIS OF THE PREVIOUSLY DEPLOYED NIR STENT IN OSTIAL RCA WAS TREATED WITH THE PLACEMENT OF A 3.50 X 13 MM NON-BSC STENT. IN (B)(6) 2010, THE SUBJECT WAS DIAGNOSED WITH UNSTABLE ANGINA (BRAUNWALD CLASSIFICATION: IIB). CARDIAC CATHETERIZATION WAS RECOMMENDED WHICH REVEALED A 75% STENOSED DE NOVO LESION LOCATED IN THE 1ST OBTUSE MARGINAL (OM). THE LESION WAS 8 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25 MM AND TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.25 X 12 MM TAXUS LIBERTE STENT, WITH 0% RESIDUAL STENOSIS. CORONARY ANGIOGRAPHY REVEALED 40-50% DIFFUSE IN-STENT RESTENOSIS AT THE PREVIOUS STENT SITE IN LIMA TO LAD WITH SPASM. THE SUBJECT WAS DISCHARGED ON ASPIRIN AND PRASUGREL THE FOLLOWING DAY. IN (B)(6) 2011, THE SUBJECT PRESENTED WITH RECURRENT AND ACCELERATING UNSTABLE ANGINA. THE SUBJECT WAS HOSPITALIZED ON SAME DAY AND CARDIAC CATHETERIZATION WAS RECOMMEND WHICH REVEALED 95% STENOSES NON-TARGET LESION LOCATED AT OSTIUM OF THE LIMA TO LAD GRAFT. THE STENOSIS WAS TREATED WITH THE PLACEMENT OF A 2.25 X 12 MM NON-BSC STENT WITH EXCELLENT RESULTS BUT THERE WAS SIGNIFICANT SPASM OF LIMA NOTED WHICH WAS TREATED WITH IMDUR AND AMLODIPINE TO PREVENT THE SPASM. "THE 95% DISCRETE LESION OF THE OSTIUM AND LIMA TO LAD, THE PROXIMAL EDGE OF THE PREVIOUSLY PLACED STENT WAS ANGIOPLASTIED WITH A 2.25 X 12 MM PROMUS DRUG ELUTING STENT." SPASM TO LIMA WAS NOTED AT THAT TIME. THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE SUBJECT WAS DISCHARGED ON ASPIRIN AND PRASUGREL, THREE DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS® LIBERTÉ® ATOM¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893612220 13420426

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R