BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1143687 · Received August 29, 2008

    Report

    Report Number
    2134265-2008-02478
    Event Type
    Injury
    Date Received
    August 29, 2008
    Date of Event
    February 6, 2006
    Report Date
    July 30, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; 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 REPORT# 2134265-2008-02476. IT WAS REPORTED THAT FOLLOWING A DRUG ELUTING STENTING TREATMENT PROCEDURE IN-STENT RESTENOSIS OCCURRED. THE INITIAL PROCEDURE WAS EMERGENT DUE TO MYOCARDIAL INFARCTION (MI) AND ONGOING CHEST PAIN. THE PT WAS GIVEN ASPIRIN, HEPARIN AND INTEGRILLIN. THE TARGET LESION WAS AN AREA OF "THROMBOTIC TOTAL OCCLUSION" IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS PREDILATED WITH A 2.5X20MM MAVERICK2 BALLOON CATHETER. A 3.0X28MM TAXUS EXPRESS2 DRUG ELUTING STENT (DES) WAS IMPLANTED IN THE PROXIMAL LAD. A 3.0X12MM TAXUS EXPRESS2 DES WAS IMPLANTED PROXIMALLY AND OVERLAPPING THE 3.0X28MM TAXUS EXPRESS2 DES. BOTH STENTS WERE POSTDILATED WITH NO RESIDUAL STENOSIS, NO DISSECTION AND BRISK FLOW. AT 647 DAYS LATER, THE PT EXPERIENCED ACUTE CHEST PAIN AND EKG CHANGES CONSISTENT WITH ACUTE MI. EMERGENT ANGIOGRAPHY REVEALED "ACUTE ANTERIOR MI AND IN-STENT RESTENOSIS". THE LESION WAS PREDILATED WITH A 2.5X20MM MAVERICKRX BALLOON CATHETER. A 3.0X32MM TAXUS EXPRESS2 DES WAS IMPLANTED AND THEN DISTALLY WITH SLIGHT OVERLAP, A 3.5X12MM TAXUS EXPRESS2 DES WAS IMPLANTED. THE FINAL RESULT NOTED NO PT COMPLICATIONS, NO RESIDUAL STENOSIS AND NO DISSECTION. POST PROCEDURE COURSE WAS UNEVENTFUL. THE PT WAS DISCHARGED 3 DAYS LATER. FIVE HUNDRED AND THIRTY FOUR DAYS FOLLOWING INTERVENTION, THE PT REQUIRED THE IMPLANT OF A NON-BSC BI-V ICD FOR THE TREATMENT OF CONGESTIVE HEART FAILURE AND DYSSYNCHRONY. THE PT REQUIRED URGENT APPENDECTOMY SURGERY EARLIER THIS YEAR TO REMOVE A GANGRENOUS APPENDIX. AT THE MOST RECENT FOLLOWUP, THE PT WAS REPORTABLY DOING "REMARKABLY WELL".

    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 3.0X12MM

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R