BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 DRUG-ELUTING CORONARY STENT

    MDR report key: 765522 · Received September 27, 2006

    Report

    Report Number
    6000093-2006-01948
    Event Type
    Injury
    Date Received
    September 27, 2006
    Date of Event
    August 28, 2006
    Report Date
    August 29, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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 8180184 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

    TAP. IT WAS REPORTED THAT 67 DAYS AFTER IMPLANTATION OF A 2.5X24MM TAXUS EXPRESS2 DRUG ELUTING STENT, AN IN-STENT RESTENOSIS OCCURRED. DURING THE INITIAL PROCEDURE, THE TARGET LESION WAS LOCATED IN THE 1ST DIAGONAL ARTERY. A PRE-INTERVENTION STENOSIS OF 75% WAS REPORTED. THE LESION WAS PRE-DILATED WITH A 3.0X15MM MAVERICK BALLOON. A 2.5X24MM TAXUS STENT WAS DEPLOYED IN THE 1ST DIAGONAL ARTERY IN THE REGION OF THE LESION. IT WAS NOT REPORTED THAT THE STENT WAS POST-DILATED. A POST-INTERVENTION RESIDUAL STENOSIS OF 0% WAS REPORTED. THE PT REC'D ANGIOMAX DURING THE PROCEDURE. COMPLICATIONS WERE REPORTED AS "NONE". THE PT PRESENTED 67 DAYS AFTER THE INITIAL PROCEDURE WITH CHEST PAIN AND A 75% IN-STENT RESTENOSIS IN THE 1ST DIAGONAL ARTERY CONFIRMED BY INTRAVASCULAR ULTRASONOGRAPHY. ATHERECTOMY OF THE 1ST DIAGONAL ARTERY WAS PERFORMED USING A 2.75X10MM CUTTING BALLOON. A POST-INTERVENTION RESIDUAL STENOSIS OF 0% WAS REPORTED. THE PT REC'D ANGIOMAX 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. 2.50X24MM 8180184

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention