BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPREE2 DRUG-ELUTING CORONARY STENT

    MDR report key: 770036 · Received October 13, 2006

    Report

    Report Number
    6000093-2006-02086
    Event Type
    Injury
    Date Received
    October 13, 2006
    Date of Event
    September 12, 2006
    Report Date
    September 15, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 7942275 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

    IT WAS REPORTED THAT 213 DAYS AFTER IMPLANTATION OF A2.5X20MM 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 OF 60% WAS REPORTED. INTRAVASCULAR ULTRASONOGRAPHY (IVUS) OF THE LAD WAS PERFORMED REVEALING "DIFFUSE DISEASE THROUGHOUT THE LAD WITH AN AREA OF DISCRETE STENOSIS IN THE MID PORTION, JUST AFTER THE SEPTAL PERFORATOR WITH A MINIMAL LUMINAL AREA OF 2.8 MILLIMETERS SQUARED IN A 3.0 DIAMETER VESSEL." ANGIOPLASTY WAS THEN PERFORMED USING A 2.5X8MM VOYAGER BALLOON. A 2.5X20MM TAXUS STENT WAS DEPLOYED IN THE LAD IN THE REGION OF THE LESION. A POST-INTERVENTION RESIDUAL STENOSIS OF 0% WITH TIMI III FLOW WAS REPORTED AND "NO DISSECTION FLAP WAS NOTED." THE PATIENT RECEIVED ANGIOMAX DURING; PLAVIX AND ASPIRIN AFTER THE PROCEDURE. POST INTERVENTION, THE PATIENT WAS NOTED TO BE" IN STABLE CONDITION, IN NO APPARENT DISTRESS." THE PATIENT PRESENTED 213 DAYS AFTER THE INITIAL PROCEDURE WITH "INCREASING CHEST PAIN" AND AN 85-90% IN-STENT RESTENOSIS AND "NATIVE VESSEL" STENOSIS IN THE MID LAD. ANGIOPLASTY WAS PERFORMED WITH A 2.5X15MM MAVERICK BALLOON. A 2.5X23MM CYPHER STENT WAS THEN DEPLOYED AT 14ATM IN THE LAD IN THE REGION OF THE LESION. THE STENT WAS POST-DILATED WITH 2.75X15MM POWERSAIL BALLOON. A POST-INTERVENTION RESIDUAL STENOSIS OF 0% WITH TIMI III FLOW WAS REPORTED AS "NO DISSECTION WAS NOTED." THE PT RECEIVED HEPARIN AND INTEGRILIN DURING THE PROCEDURE. POST INTERVENTION THE PATIENT WAS REPORTEDLY "IN STABLE CONDITION, IN NO APPARENT DISTRESS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPREE2 DRUG-ELUTING CORONARY STENT DRUG COATED STENT NIQ BOSTON SCIENTIFIC CORP. 2.5X20MM 7942275

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other| R