BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 553633 · Received November 4, 2004

    Report

    Report Number
    6000089-2004-01372
    Event Type
    Injury
    Date Received
    November 4, 2004
    Report Date
    October 6, 2004
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS ENROLLED IN THE PROGRAM IN 2004. A 3.0 X 8 MM TAXUS STENT WAS ATTEMPTED TO BE PLACED IN THE DISTAL RCA BUT WAS UNSUCCESSFUL AND WAS PLACED IN TARGET LESION 1 (MID RCA). TARGET LESION 1 WAS IDENTIFIED IN THE MID RCA WITH 70% STENOSIS AND A 3.0 MM REFERENCE VESSEL DIAMETER. TARGET LESION 1 WAS TREATED WITH PLACEMENT OF A 3.0 X 8 MM TAXUS STENT. RESIDUAL STENOSIS WAS 0% FOLLOWING POST-DILATATION. POST STENT PLACEMENT, DEPLOYMENT BALLOON WAS ATTEMPTED TO DILATE THE DISTAL RCA; HOWEVER, WAS UNSUCCESSFUL. TARGET LESION 2 WAS THEN IDENTIFIED IN THE DIST RCA 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 8 MM TAXUS STENT. RESIDUAL STENOSIS WAS 0% FOLLOWING POST-DILATATION. THE PT WAS DISCHARGED THE 2ND DAY ON PLAVIX AND ASA. CONSULTATION NOTED DATE 07/04 STATES THAT THE PT HAD RECENTLY PRESENTED TO THE ER WITH INCREASED SHORTNESS OF BREATH, ORTHOPNEA AND PND. THE PT WAS GIVEN DIURETICS AND RELEASED. A FEW DAYS LATER, THE PT PRESENTED AGAIN BECAUSE OF MORE SHORTNESS OF BREATH AND CHEST DISCOMFORT. THE TROPONINS WERE POSITIVE (0.39) INDICATING A SMALL NON-Q-WAVE MI (PER CONSULTATION NOTE). SITE CONFIRMED THAT MI DID NOT MEET PROTOCOL CRITERIA. TWO DAYS LATER, THE PT WAS TRANSFERRED TO THE STUDY SITE FOR CARDIAC CATHETERIZATION. CARDIAC CATHETERIZATION IN 2004 (87 DAYS POST ENROLLMENT) REVEALED: RCA - 99% DISTAL SUBTOTAL OCCLUSION, 70% PROXIMAL MID STENOSIS, LUMINAL IRREGULARITIES IN THE R-PDA AND RPL, LMCA - 20% OSTIAL IRREGULARITY, LAD - 80% STENOSIS OF THE 1ST DIAG, 40% STENOSIS OF THE 2ND DIAG, LCX - 100% OCCLUDED. A 3.0 X 20 MM TAXUS STENT WAS DEPLOYED IN THE DIST RCA JUST BEFORE TAKEOFF OF THE PDA WITH 0% RESIDUAL STENOSIS. NEXT, A 3.5 X 16 MM TAXUS STENT WAS DEPLOYED IN THE PROX RCA AND WAS OVERLAPPED DISTALLY WITH A 3.5 X 8 MM TAXUS STENT. RESIDUAL STENOSIS WAS 0%. THE PT WAS DISCHARGED 3 DAYS LATER ON PLAVIX AND ASA. IN THE OPINION OF THE PHYSICIAN, THE RELATIONSHIP TO THE TAXUS STENT IS "UNKNOWN."

    Description of Event or Problem · 1

    SAME CASE AS MFR #6000089-2004-01373. CLINICAL STUDY. IT WAS REPORTED THAT 2 MONTHS AFTER A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, A TARGET VESSEL REINTERVENTION WAS PERFORMED ON A RIGHT CORONARY ARTERY LESION.

    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 8.0 MM 6336662

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention