BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 2770658 · Received October 3, 2012

    Report

    Report Number
    2134265-2012-05967
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    December 8, 2011
    Report Date
    September 4, 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

    (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) STUDY. SAME PATIENT AS MDR ID#: 2134265-2012-05968, 2134265-2012-05965, 2134265-2012-05966. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, THE PATIENT HAD CHEST PAIN AND MYOCARDIAL INFARCTION (MI). IN (B)(6) 2010, THE PATIENT PRESENTED WITH NON ST-ELEVATION MYOCARDIAL INFARCTION (KILLIP CLASS I) AND CARDIAC CATHETERIZATION WAS RECOMMENDED. THE 1ST TARGET LESION WAS LOCATED IN THE 1ST OBTUSE MARGINAL BRANCH (OM1) WITH 90% STENOSIS AND WAS 15MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATION AND PLACEMENT OF A 3.00X20MM TAXUS LIBERTE STENT, WITH 0% RESIDUAL STENOSIS. THE 2ND TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (MID LAD) WITH 80% STENOSIS AND WAS 40MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATION AND PLACEMENT OF TWO TAXUS LIBERTE STENTS OF SIZE 3.00X16MM AND 3.00X38MM, WITH 0% RESIDUAL STENOSIS. THE 3RD TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (PROX LAD) WITH 70% STENOSIS AND WAS 10MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATION AND PLACEMENT OF A 3.00X12MM TAXUS LIBERTE STENT, WITH 0% RESIDUAL STENOSIS FOLLOWING POST-DILATION. THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. IN (B)(6) 2011, THE PATIENT PRESENTED WITH LEFT NECK PAIN, SHOULDER PAIN AND CHEST PAIN WHICH WAS LASTING FOR ONE DAY AND THE PATIENT WAS HOSPITALIZED ON THE SAME DAY. THE NECK PAIN WAS SECONDARY TO HERNIATED DISK AND NO INTERVENTION WAS PROVIDED. THE PATIENT STOPPED TAKING HIS MEDICATIONS EXCEPT ASPIRIN "A FEW DAYS" BEFORE THIS EVENT. ECG REVEALED NON ST-ELEVATION MYOCARDIAL INFARCTION AND THE PATIENT EXPERIENCED ISCHEMIC SYMPTOMS. CARDIAC ENZYMES WERE FOUND TO BE ELEVATED WHICH CONFIRMED A NON Q-WAVE MYOCARDIAL INFARCTION. THE PATIENT RECEIVED ONE DOSE OF CLOPIDOGREL IN THE EMERGENCY ROOM AND WAS NOT GIVEN A PRESCRIPTION. NO ACTION WAS TAKEN WITH REGARDS TO THE STUDY DRUG. THE PATIENT REFUSED CARDIAC CATHETERIZATION AND LEFT HOSPITAL AGAINST MEDICAL ADVICE. THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893612300 13190503

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization