BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1040189 · Received May 8, 2008

    Report

    Report Number
    2134265-2008-01335
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    July 26, 2005
    Report Date
    April 15, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE STENT WAS NOT EXPLANTED FROM THE HEART. THE HEART WAS TRANSPLANTED IN 2007. DEVICE ANALYSIS: 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

    SAME CASE AS MFR#2134265-2008-01333, 2134265-2008-01332, 2134265-2008-01334. IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT THROMBOSIS AND STENT EXPLANTATION OCCURRED. THE PT SUFFERED AN ANTERIOR WALL MYOCARDIAL INFARCTION. THE PHYSICIAN PLACED FOUR TAXUS EXPRESS2 DRUG ELUTING STENTS IN THE PROXIMAL, MID, AND DISTAL LEFT ANTERIOR DESCENDING (LAD) AND THE 1ST OBTUSE MARGINAL (OM1). FIVE DAYS LATER, THE PT SUFFERED CARDIOGENIC SHOCK AND IN-STENT THROMBOSIS OF THE LAD AND OM1 FOR WHICH THE PT HAD A BIVENTRICULAR ASSIST DEVICE PLACED. THE PT'S POSTOPERATIVE COURSE WAS COMPLICATED BY FEVER AND RENAL FAILURE. THE PT EVENTUALLY RECOVERED AND WAS RELEASED HOME 32 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. AT 335 DAYS AFTER THE PT WAS SENT HOME, HE WAS READMITTED FOR A MALFUNCTIONING RIGHT VENTRICULAR ASSIST DEVICE, WHICH WAS REMOVED THE NEXT DAY. THE PT SUBSEQUENTLY REMAINED IN THE HOSPITAL ON THE HEART TRANSPLANT LIST. THE PT SUFFERED ENTEROCOCCAL BACTERIEMIA WHICH REQUIRED A THREE MONTH COURSE OF VANCOMYCIN. THE PT BRIEFLY REQUIRED CONTINUOUS VENO - VENOUS HEMOFILTRATION, BUT RENAL FUNCTION EVENTUALLY RECOVERED. AT 513 DAYS POST THE INITIAL STENT IMPLANTATION, THE PT UNDERWENT A SUCCESSFUL HEART TRANSPLANT. SUBSEQUENT POST-TRANSPLANT EVALUATIONS SHOW NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM NIQ STENT, CORONARY, DURG-ELUTING NIQ BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention