BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS (R) LIBERTÉ (R)

    MDR report key: 2213096 · Received August 16, 2011

    Report

    Report Number
    2134265-2011-03648
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 21, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS A COMBINATION PRODUCT. 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    (B)(4). SAME CASE AS 2134265-2011-03649. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE THE PATIENT EXPERIENCED RESTENOSIS. DURING THE INDEX PROCEDURE CORONARY ANGIOGRAPHY REVEALED IN-STENT RESTENOSIS OF A PREVIOUSLY PLACED TAXUS STENT IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 60% STENOSIS AND WAS 8 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.75 MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION, CUTTING BALLOON ANGIOPLASTY, AND IMPLANTING A 3.5 X 12 MM TAXUS LIBERTE STUDY STENT AND POST DILATATION WITH 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND PRASUGREL. AT 204 DAYS POST INDEX PROCEDURE, THE PATIENT WAS ADMITTED WITH UNSTABLE ANGINA AND DIAGNOSED WITH A NON- ST ELEVATION MYOCARDIAL INFARCTION. THE CORONARY ANGIOGRAM REVEALED THE PREVIOUSLY PLACED PROXIMAL STENT IN THE LAD HAD 40% DISCRETE INSTENT RESTENOSIS AND THE PREVIOUSLY PLACED STUDY STENT HAD A 90% INSTENT RESTENOSIS WITH MINIMAL PLAQUE IN THE DISTAL LAD. THE LAD WAS TREATED WITH PREDILATATION, PLACEMENT OF A 4.0 X 23 MM PROMUS DRUG ELUTING STENT. FOLLOW-UP ANGIOGRAPHY REVEALED MINOR SPASM WHICH WAS TREATED WITH INTRACORONARY NITROGLYCERIN. THE STENT WAS THEN POST DILATED WITH A 4.0 QUANTUM MAVERICK WITH 0% RESIDUAL STENOSIS AND TIMI 3 FLOW. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND PRASUGREL.

    Description of Event or Problem · 1

    (B)(4) STUDY. SAME CASE AS 2134265-2011-03649. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE THE PATIENT EXPERIENCED RESTENOSIS. DURING THE INDEX PROCEDURE CORONARY ANGIOGRAPHY REVEALED IN-STENT RESTENOSIS OF A PREVIOUSLY PLACED TAXUS STENT IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 60% STENOSIS AND WAS 8 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.75 MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION, CUTTING BALLOON ANGIOPLASTY, AND IMPLANTING A 3.5 X 12 MM TAXUS LIBERTE STUDY STENT AND POST DILATATION WITH 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND PRASUGREL. AT 204 DAYS POST INDEX PROCEDURE, THE PATIENT WAS ADMITTED WITH UNSTABLE ANGINA AND DIAGNOSED WITH A NON- ST ELEVATION MYOCARDIAL INFARCTION. THE CORONARY ANGIOGRAM REVEALED THE PREVIOUSLY PLACED PROXIMAL STENT IN THE LAD HAD 40% DISCRETE INSTENT RESTENOSIS AND THE PREVIOUSLY PLACED STUDY STENT HAD A 90% INSTENT RESTENOSIS WITH MINIMAL PLAQUE IN THE DISTAL LAD. THE LAD WAS TREATED WITH PREDILATATION, PLACEMENT OF A 4.0 X 23 MM PROMUS DRUG ELUTING STENT. FOLLOW-UP ANGIOGRAPHY REVEALED MINOR SPASM WHICH WAS TREATED WITH INTRACORONARY NITROGLYCERIN. THE STENT WAS THEN POST DILATED WITH A 4.0 QUANTUM MAVERICK WITH 0% RESIDUAL STENOSIS AND TIMI 3 FLOW. THE PATIENT WAS DISCHARGED THE NEXT DAY 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 H7493893612350 13533293

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention