BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 537641 · Received August 3, 2004

    Report

    Report Number
    6000093-2004-00707
    Event Type
    Injury
    Date Received
    August 3, 2004
    Date of Event
    June 26, 2004
    Report Date
    July 9, 2004
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PT WAS ENROLLED INTO THE PROGRAM IN 2004. TARGET LESION 1 (16MM LONG) WAS IDENTIFIED IN THE PEOXIMAL WITH 90% STENOSIS AND A 3.5MM REFERENCE VESSEL DIAMETER. TARGET LESION 1 WAS TREATED WITH PREDILATATION AND PLACEMENT OF A 3.5 X 20 MM TAXUS STENT, WITH 0%. TARGET LESION 2 WAS IDENTIFIED IN THE PROXNAL CIRCUMFLEX WITH 95% STENOSIS AND A 3.0 MM REFERENCE VESSEL DIAMETER. TARGET LESION 2 WAS TREATED WITH PREDILATATION AND PLACEMENT OF A 3.0 X 12 MM TAXUS STENT. THE STENT WAS FULLY EXPANDED, HOWEVER, THERE WAS DIFFICULTY ENCOUNTERED TRYING TO REMOVE THE BALLOON FROM THE STENT. EVENTUALLY THE BALLOON WAS REMOVED BUT DURING THE PROCESS THE GUIDE WIRE WAS DISLODGED INTO THE PROXIMAL CIRCUMFLEX. FOLLOWING INJECTION A DISSECTION WAS NOTED RESULTING IN TIMI-I ANTEGRADE FLOW. SEVERAL ATTEMPTS TO NEGOTIATE THE DISTAL LUMEN WERE UNSUCCESSFUL. THE PT COMPLAINED OF CHEST PAIN. AN INTRA-AORTIC BALLOON PUMP WAS PLACED AND CARDIO-THORACIC SURGERY OPINION WAS THE RISK-BENEFIT RATIO MADE THE PT A POOR SURGICAL CANDIDATE. THEREFORE, WITH THE PT PAIN-FREE AND HEMODYNAMILLY STABLE AND WITH NO ACUTE EKG CHANGES, THE PT WAS TRANSFERRED TO THE CCU TO 'RIDE 0UT' THE DISSECTION WITH OCCLUSION OF THE DISTAL CIRCUMFLEX. THE PT WAS ADMITTED WITH UNSTABLE ANGINA TWO MONTHS LATER. CARDIAC CATHERIZATION REVEALED: LMCA - WIDELY PATENT, LAD - WIDELY PATENT PROXIMAL STENT, MILD TO MODERATE IRREGULARITIES IN THE DISTAL SEGMENT, 60-70% STENOSIS OF THE 1ST DIAG, LCX - SUBTOTALLY STENOSED PROXIMALLY, RAMUS - 60-70% OSTIAL AND PROXIMAL STENOSIS. A 3.0 X 18 MM CYPHER STENT WAS DEPLOYED IN THE PROX LCX. RESIDUAL STENOSIS WAS 0%. THERE WERE NO REPORTED COMPLICATIONS AND THE PT WAS DISCHARGED THE NEXT DAY. IN THE OPINION OF THE PHYSICIAN THE RELATIONSHIP OF THE EVENT TO THE TAXUS STENT IS "PROBABLE."

    Description of Event or Problem · 1

    CLINICAL STUDY. SAME CASE AS MFR # 6000093-2004-00708. TWO MONTHS AFTER A DRUG ELUTING STENTING TREATMENT PROCEDURE, A TARGET VESSEL REINTERVENTION WAS PERFORMED ON THE LEFT ANTERIOR DESCENDING AND LEFT CIRCUMFLEX ARTERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM DRUG COATED STENT NIQ BOSTON SCIENTIFIC TAXUS EXPRESS2 8.8% 3.00 X 12 MM 6295004

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention