BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1860728 · Received October 7, 2010

    Report

    Report Number
    2134265-2010-04589
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    April 12, 2010
    Report Date
    September 15, 2010
    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 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). IT WAS REPORTED THAT FOLLOWING A STENTING TREATMENT PROCEDURE, THE PATIENT PRESENTED WITH IN STENT RESTENOSIS. THE INDEX PROCEDURE PLACED AN UNSPECIFIED TAXUS LIBERTE STENT IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY ON AN UNSPECIFIED DATE. IN (B)(6) 2010, QCA EVALUATION REVEALED A 79% RESTENOSED, 2.83X13.3MM TARGET LESION LOCATED IN THE MID LAD WITH TIMI 3 FLOW. TREATMENT UTILIZED A CUTTING BALLOON AND ANGIOPLASTY RESULTING IN 23% RESIDUAL STENOSIS AND TIMI 3 FLOW. NO ANGINA WAS CONFIRMED AT THE 9 MONTH AND 1 YEAR STUDY FOLLOW UP VISITS. PER THE PHYSICIAN, THE EVENT WAS LISTED AS "POSSIBLY RELATED" TO THE STUDY STENT.

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #: 2134265-2011-00645. IT WAS FURTHER REPORTED THAT THE INDEX PROCEDURE TREATED THE 2.5X32MM TARGET LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. TREATMENT CONSISTED OF PRE-DILATION AND THE PLACEMENT OF TWO OVERLAPPING 2.5X32MM TAXUS LIBERTE STENTS RESULTING IN 0% RESIDUAL STENOSIS. A NON-TARGET LESION LOCATED IN THE PROXIMAL LAD WAS TREATED WITH A NON BSC STENT. AFTER SCHEDULED TREATMENT FOR ANOTHER LESION, THE PATIENT WAS DISCHARGED WITHOUT COMPLICATION 12 DAYS LATER ON ASPIRIN AND TICLOPIDINE. IT WAS NOTED THAT THE PATIENT DID NOT HAVE ISCHEMIC SYMPTOM AT THE REVASCULARIZATION PROCEDURE IN (B)(6) 2010, AND WAS DISCHARGED TWO DAYS POST THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493893632250

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R CYPHER STENT| 2.5X32MM TAXUS LIBERTE