BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1890401 · Received November 3, 2010

    Report

    Report Number
    2134265-2010-04903
    Event Type
    Injury
    Date Received
    November 3, 2010
    Date of Event
    September 24, 2010
    Report Date
    October 8, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    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).

    Description of Event or Problem · 1

    (B)(4) CLINICAL STUDY. SAME CASE AS MFR REPORT #: 2134265-2010-04904. IT WAS REPORTED THAT FOLLOWING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE PATIENT PRESENTED WITH THROMBOSIS. THE PATIENT PRESENTED DUE TO A MYOCARDIAL INFARCTION AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE INDEX PROCEDURE TREATED THE 90% STENOSED, 2.5X20MM TARGET LESION LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. TREATMENT CONSISTED OF PRE DILATION, THE PLACEMENT OF A 2.5X28MM TAXUS LIBERTE STENT AND POST DILATION RESULTING IN 0% RESIDUAL STENOSIS. TWO DAYS POST THE INDEX PROCEDURE, THE PATIENT WAS IN THE PROCESS OF BEING DISCHARGED FROM HIS INDEX PROCEDURE WHEN HE DEVELOPED ACUTE CHEST DISCOMFORT AND DYSPNEA. AN ECG SHOWED DRAMATIC ANTERIOR ST-SEGMENT ELEVATIONS AND THE SUBJECT WAS TAKEN URGENTLY TO THE CARDIAC CATHETERIZATION LAB FOR ANGIOGRAPHY WHICH REVEALED AN ACUTE THROMBOTIC OCCLUSION BEYOND THE PREVIOUSLY PLACED STENT IN THE DISTAL LAD. A THROMBECTOMY WAS PERFORMED WHICH RE-ESTABLISHED TIMI 3 FLOW IN THE DISTAL VESSEL AND RESOLVED THE ECG CHANGES AND ANGINA. HOWEVER, POST IVUS REVEALED SOMEWHAT UNDER-DEPLOYED STENTS WITH EXTENSIVE MEDIAL HYPERPLASIA AND AN EDGE DISSECTION. TREATMENT PLACED A 2.75 X 12MM TAXUS LIBERTE STENT IN OVERLAPPING FASHION WITH THE PREVIOUSLY PLACED INDEX STENT. SERIAL DILATATIONS WERE PERFORMED USING A 3.0 X 20MM QUANTUM MAVERICK NONCOMPLIANT BALLOON AT HIGH ATMOSPHERIC PRESSURE BUT IVUS REVEALED PERSISTENTLY UNDER-DEPLOYED STENTS. REPEAT DILATATIONS USING THE SAME NONCOMPLIANT BALLOON AT HIGH ATMOSPHERES WERE PERFORMED, BUT IVUS STILL SHOWED UNDER-DEPLOYED PROXIMAL STENTS. A 3.25 QUANTUM MAVERICK BALLOON WAS USED AT 16 TO 18 ATMS FOR PROLONGED INFLATIONS OF UP TO A MINUTE AT A TIME. REPEAT IMAGES AT THIS POINT REVEALED EXCELLENT ANGIOGRAPHIC RESULT WITHOUT EVIDENCE OF RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED 4 DAYS POST THE INDEX PROCEDURE ON ASPIRIN AND PRASUGREL. PER THE PHYSICIAN, THE RELATION OF THE STUDY STENT TO THE THROMBOSIS EVENT WAS LISTED AS "HIGHLY PROBABLE."

    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 - MAPLE GROVE H7493893628250 13358101

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention