BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ® LONG

    MDR report key: 2942211 · Received February 4, 2013

    Report

    Report Number
    2134265-2013-00283
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 7, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS 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 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

    STENT INITIALLY REPORTED AS IMPLANTED IN A 12MM LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 20% RESIDUAL STENOSIS AND NOW REPORTED AS IMPLANTED IN A 22MM LONG LESION IN THE PROXIMAL TO MID LAD WITH LESS THAN 20% RESIDUAL STENOSIS. IT IS FURTHER REPORTED THAT AT THE TIME OF THE EVENT, ELECTROCARDIOGRAPH REVEALED SINUS RHYTHM WITH POOR R - WAVE PROGRESSION AND SLIGHT T - WAVE INVERSIONS IN THE LATERAL V LEADS.

    Description of Event or Problem · 1

    (B)(4) CLINICAL STUDY. SAME CASE AS MDR# 65-2013-00284. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, IN STENT RESTENOSIS AND A MYOCARDIAL INFARCTION OCCURRED. IN (B)(6) 2011, THE PATIENT PRESENTED WITH STABLE ANGINA AND CARDIAC CATHETERIZATION WAS RECOMMENDED. THE FIRST, 80% STENOSED, 12 X 3.0MM, TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE FIRST TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.00 X 38 MM TAXUS LIBERTE STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 20%. THE SECOND, 90% STENOSED, 10 X 3.0MM TARGET LESION WAS LOCATED IN THE PROXIMAL LAD. THE SECOND TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF ANOTHER 3.00 X 38 MM TAXUS LIBERTE STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 20%. THE PATIENT WAS DISCHARGED THE SAME DAY ON ASPIRIN AND PRASUGREL. IN (B)(6) 2013, THE PATIENT PRESENTED WITH A 2 DAY HISTORY OF LEFT SIDED CHEST PAIN RADIATING TO THE LEFT SHOULDER AND ARM HOSPITALIZED ON THE SAME DAY. THE PATIENT WAS DIAGNOSED WITH NON - ST ELEVATION MYOCARDIAL INFARCTION AND CARDIAC CATHETERIZATION WAS RECOMMENDED. THE 90% IN-STENT RESTENOSIS OF THE STUDY STENT IN MID LAD WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.50 X 18 MM NON-BSC DRUG ELUTING STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 10%. THE NEXT DAY, THE EVENT WAS CONSIDERED TO BE RESOLVED WITHOUT RESIDUAL EFFECTS AND THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT PRESENTED FOR THE INDEX PROCEDURE WITH SHORTNESS OF BREATH AND CHEST PRESSURE. THE ONLY STENT IMPLANTED AT THAT TIME WAS IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE IN-STENT RESTENOSIS FOUND DURING THE EVENT WAS DIFFUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46473 TAXUS® LIBERTÉ® LONG CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893638300 13749384

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R