BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 DRUG-ELUTING CORONARY STENT

    MDR report key: 768767 · Received October 10, 2006

    Report

    Report Number
    6000093-2006-02043
    Event Type
    Injury
    Date Received
    October 10, 2006
    Date of Event
    September 7, 2006
    Report Date
    September 11, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE STENT REMAINS IMPLANTED AND THE DELIVERY DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT. THE MANUFACTURING RECORDS FOR TOP ASSEMBLY BATCH 7900392 HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. SHOULD FURTHER RELEVANT INFORMATION BECOME AVAILABLE; A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    SAME CASE AS MANUFACTURE'S REPORT #. TAP. IT WAS REPORTED THAT 261 DAYS AFTER IMPLANTATION OF TWO 3.0X12MM TAXUS EXPRESS2 DRUG ELUTING STENTS, IN-STENT RESTENOSIS OCCURRED. DURING THE INITIAL PROCEDURE, THE TARGET LESION WAS LOCATED IN THE DISTAL LEFT CIRCUMFLEX ARTERY (LCX). A PRE-INTERVENTION STENOSIS OF 60% WAS REPORTED. IT WAS NOT REPORTED THAT THE LESION WAS PRE-DILATED. A 3.0X12MM TAXUS STENT WAS DEPLOYED IN THE DISTAL LCX IN THE REGION OF THE LESION. FOLLOW UP ANGIOGRAM DEMONSTRATED "SIGNIFICANT LUMEN NARROWING IMMEDIATELY PROXIMAL TO THE DEPLOYED STENT" INDICATIVE OF "POSSIBLE EDGE DISSECTION." SUBSEQUENTLY, AN ADDITIONAL 3.0X12MM TAXUS STENT WAS DEPLOYED PROXIMALLY OVERLAPPING THE PREVIOUSLY DEPLOYED STENT. A POST-INTERVENTION RESIDUAL STENOSIS OF 0% WITH TIMI GRADE III FLOW WAS REPORTED. THE PATIENT RECEIVED ASPIRIN PRIOR; HEPARIN AND ANGIOMAX DURING; AND PLAVIX AFTER THE PROCEDURE. THERE WERE REPORTEDLY "NO COMPLICATIONS." THE PATIENT PRESENTED 261 DAYS AFTER THE INITIAL PROCEDURE WITH "ATYPICAL CHEST PAIN" AND A 60% IN-STENT RESTENOSIS WITH TIMI GRADE II "PARTIAL FLOW/PERFUSION" IN THE LCX. INTRAVASCULAR ULTRASONOGRAPHY WAS PERFORMED ON THE LCX. A 3.0X28MM CYPHER DRUG ELUTING STENT WAS THEN DEPLOYED AT 16 ATM IN THE LCX IN THE REGION OF THE LESION. A POST-INTERVENTION RESIDUAL STENOSIS WAS NOT REPORTED. THE PATIENT RECEIVED INTRACORONARY NITROGLYCERIN DURING THE PROCEDURE. COMPLICATIONS WERE REPORTED AS "NONE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 DRUG-ELUTING CORONARY STENT DRUG COATED STENT NIQ BOSTON SCIENTIFIC CORP. 3.0X12MM 7900392

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other| R