BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1002293 · Received February 22, 2008

    Report

    Report Number
    2134265-2008-00513
    Event Type
    Injury
    Date Received
    February 22, 2008
    Date of Event
    July 8, 2005
    Report Date
    January 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT 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 INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    CLINICAL TRIAL. SAME CASE AS MFR# 2134265-2008-00527. IT WAS REPORTED THAT DURING A CLINICAL TRIAL DRUG ELUTING STENTING PROCEDURE, A DISSECTION AND NO REFLOW OCCURRED. THE PATIENT PRESENTED TO THE INDEX PROCEDURE WITH AN ACUTE MYOCARDIAL INFARCTION (MI). THE INDEX LESION WAS A DE NOVO LESION IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THE LESION WAS 3.7 MM WIDE, 28 MM LONG, AND 90% STENOSED. THE PHYSICIAN PREDILATED THE LESION, WHICH RESULTED IN EXCELLENT TIMI 3 FLOW. A 3.5 X 32 MM TAXUS STENT WAS THEN PLACED. THE PT HAD MARKED ST ELEVATIONS AND MARKED NO REFLOW. LEVOPHED NITROPRUSSIDE AND NEO-SYNEPHRINE WERE GIVEN TO RESUSCITATE THE PATIENTS BLOOD PRESSURE. THE PATIENT DID NOT ARREST. TIMI 2 FLOW WAS RESTORED. THE PHYSICIAN THEN PLACED AN EXPORT CATHETER AND GAVE MORE NITROPRUSSIDE. IN THE PROCESS OF PLACING THE EXPORT, THE PROXIMAL VESSEL APPEARED TORN. THE PHYSICIAN WAS CONCERNED A DISSECTION OCCURRED. THERE WAS DIMINISHED FLOW INTO THE RCA AND AGAIN MARKED ST ELEVATION. THE PHYSICIAN THEN PLACED A 3.5 X 28 MM TAXUS STENT IN OVERLAPPING FASHION WHICH RESULTED IN NO REFLOW, BUT RESPONDED TO NITROPRUSSIDE. THE STENTS APPEARED UNDERSIZED. THE PHYSICIAN THUS POST DILATED WHICH RESULTED IN NO FURTHER EPISODES AND NO REFLOW EXCEPT SOME DEGRADATION OF FLOW. THE PHYSICIAN GAVE COPIOUS AMOUNT OF NITROPRUSSIDE AND WAS FINALLY ABLE TO ACHIEVE COMPLETE TIMI 3 FLOW WITHOUT ANY EVIDENCE OF DISTAL EMBOLIZATION. THE EVENT WAS CONSIDERED RESOLVED. IN THE OPINION OF THE PHYSICIAN, THERE WAS A DEFINITE RELATIONSHIP BETWEEN THE EVENT AND THE TAXUS STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM NIQ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC CORPORATION 3.5 X 32MM 7280187

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| R