BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS (R) LIBERTÉ (R)

    MDR report key: 2161447 · Received July 14, 2011

    Report

    Report Number
    2134265-2011-02645
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    May 7, 2010
    Report Date
    June 14, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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)(6). SAME CASE AS: 2134265-2011-02644, 2134265-2011-02643. SAME PATIENT AS: 2134265-2010-01005. IT WAS REPORTED THAT POST A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED RESTENOSIS. DURING THE INDEX PROCEDURE, TARGET LESION 1 WAS A DE NOVO, 90% STENOSED LESION OF THE LMCA (LEFT MAIN CORONARY ARTERY). TARGET LESION 1 WAS TREATED WITH DIRECT STENTING USING A 3.5X20MM TAXUS LIBERTE. A DISSECTION OCCURRED DURING STENT IMPLANTATION. NO ACTION WAS TAKEN FOR THE DISSECTION AND THE STENT WAS POST DILATED WITH A 3.0X15MM BALLOON RESULTING IN 0% RESIDUAL STENOSIS AND A WELL EXPANDED STENT ON IVUS (INTRAVASCULAR ULTRASOUND) EXAMINATION. TARGET LESION TWO WAS A DE NOVO, 2.71X47MM, 90% STENOSED LESION OF THE MID LAD (LEFT ANTERIOR DESCENDING). TREATMENT CONSISTED OF DIRECT STENTING USING TWO OVERLAPPING TAXUS LIBERTE STENTS (3.0X20MM AND 3.0X16MM) RESULTING IN 0% RESIDUAL STENOSIS AND WELL EXPANDED STENTS ON IVUS EXAMINATION. IN (B)(6) 2010, THE PATIENT EXPERIENCED RESTENOSIS. THE 99% STENOSED TARGET LESION BEING TREATED WAS 3.5MM IN DIAMETER AND 30MM LONG LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD). A TARGET VESSEL INTERVENTION WAS PERFORMED WITH THE PLACEMENT OF TWO (3.0X18MM AND 3.5X12MM) PROMUS STENTS. RESIDUAL STENOSIS WAS 0%. THE PATIENT OUTCOME WAS IMPROVED.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE INDEX PROCEDURE TARGET LESION 1 WAS 3.5MM IN DIAMETER AND 20MM LONG. POST DILATION WAS PERFORMED AND TIMI 3 FLOW WAS KEPT THROUGH THE PROCEDURE. THE PATIENT WAS DISCHARGED WITHOUT COMPLICATIONS 8 DAYS LATER ON ASPIRIN AND CLOPIDOGREL BISULFATE. IN (B)(6) 2010, THE PATIENT DID NOT HAVE ISCHEMIC SYMPTOMS. THE LESION LOCATED IN THE MID AND DISTAL LAD NOT JUST THE MID LAD AS PREVIOUSLY REPORTED. TIMI 3 FLOW WAS KEPT THROUGH THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS (R) LIBERTÉ (R) CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493893616300

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention