BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 2962583 · Received February 14, 2013

    Report

    Report Number
    2134265-2013-00585
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    October 26, 2012
    Report Date
    January 16, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS A COMBINATION PRODUCT. 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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, THE PATIENT HAD MYOCARDIAL INFARCTION (MI) AND REQUIRED A TARGET VESSEL REVASCULARIZATION (TVR). IN DEC 2010, THE PATIENT PRESENTED WITH UNSTABLE ANGINA (BRAUNWALD CLASSIFICATION-IIIB) AND CARDIAC CATHETERIZATION WAS RECOMMENDED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (PROX LAD) WITH 70% IN-STENT STENOSIS AND WAS 12MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATION AND PLACEMENT OF A 3.50X24MM TAXUS LIBERTE STENT, WITH 0% RESIDUAL STENOSIS FOLLOWING POST-DILATION. THE JAILED DIAGONAL BRANCH WAS ALSO TREATED WITH BALLOON ANGIOPLASTY, WITH 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. IN OCT 2012, THE PATIENT PRESENTED WITH CHEST PAIN RADIATING TO LEFT ARM AND ASSOCIATED WITH NAUSEA, SHORTNESS OF BREATH, AND DIAPHORESIS. ECG INDICATED POSSIBLE ISCHEMIA. CARDIAC ENZYMES WERE ELEVATED INDICATING A MYOCARDIAL INFARCTION. SUBTOTAL OCCLUSION WITH THROMBUS WAS NOTED IN THE 1ST DIAGONAL BRANCH, WHICH WAS TREATED WITH PLACEMENT OF A 2.50X12MM ION STENT. FOLLOWING KISSING BALLOON ANGIOPLASTY, RESIDUAL STENOSIS WAS 0%. AT THE TIME OF THE EVENT, THE PATIENT WAS ON ASPIRIN ONLY. LAST DOSE OF STUDY DRUG WAS TAKEN IN AUG 2012. THE EVENT WAS CONSIDERED AS RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65947 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893624350 13200051

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention