BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 DRUG-ELUTING CORONARY STENT

    MDR report key: 768765 · Received October 6, 2006

    Report

    Report Number
    6000089-2006-02207
    Event Type
    Injury
    Date Received
    October 6, 2006
    Date of Event
    February 28, 2006
    Report Date
    September 7, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 #8213216 HAVE BEEN REVIEWED AND NO ISSUES FOR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. SHOULD FURTHER RELEVANT INFO BECOMES AVAILABLE; A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 191 DAYS AFTER IMPLANTATION OF A 3.0X12MM TAXUS EXPRESS2 DRUG ELUTING STENT, AN IN-STENT RESTENOSIS OCCURRED. DURING THE INITIAL PROCEDURE, THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). A PRE-INTERVENTION STENOSIS PERCENTAGE WAS NOT REPORTED. IT WAS NOT REPORTED THAT THE LESION WAS PRE-DILATED. A 3.0X12MM TAXUS STENT WAS DEPLOYED AT 12 ATM IN THE LAD IN THE REGION OF THE LESION. IT WAS NOT REPORTED THAT THE LESION WAS POST-DILATED. THE PT REC'D HEPARIN DURING AND PLAVIX AFTER THE PROCEDURE. NO INFORMATION CONCERNING COMPLICATIONS WAS REPORTED. THE PT PRESENTED 191 DAYS AFTER THE INITIAL PROCEDURE WITH 70% IN-STENT RESTENOSIS IN THE MID LAD. IT WAS NOT REPORTED THAT THE LESION WAS PRE-DILATED. A 3.0X16MM TAXUS STENT WAS DEPLOYED AT 16 ATM IN THE MID LAD IN THE REGION OF THE LESION. A POST-INTERVENTION RESIDUAL STENOSIS WAS NOT REPORTED. THE PT REC'D HEPARIN DURING AND PLAVIX AFTER THE PROCEDURE. COMPLICATIONS WERE REPORTED AS "NONE." THE PT'S CONDITION WAS NOTED TO BE 'SATISFACTORY/GOOD."

    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 8213216

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention