BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1081439 · Received July 25, 2008

    Report

    Report Number
    2134265-2008-02100
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    July 16, 2008
    Report Date
    July 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME CASE AS #2134265-2008-02098 AND 02099. IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, RESTENOSIS OCCURRED. THE PATIENT PRESENTED IN AUGUST 2004 WITH COMPLAINTS OF CHEST PAIN. CARDIAC CATH FOUND 100% OCCLUSION OF THE PROXIMAL RIGHT CORONARY ARTERY (RCA), 70% OCCLUSION OF THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY AND 100% OCCLUSION OF THE LAD DISTALLY AND 80-90% OCCLUSION OF THE CIRCUMFLEX (CX) ARTERY. THE RCA WAS TOTALLY OCCLUDED AT THE TERMINATION OF THE PROXIMAL THIRD WITH VISIBLE THROMBUS. THE LESION WAS PREDILATED WITH A 3.0 X 20 MM MAVERICK BALLOON AND THE PHYSICIAN REMOVED THROMBUS WITH A THROMBECTOMY DEVICE. TWO TAXUS EXPRESS2 DRUG ELUTING STENTS, SIZES 3.5 X 24 MM AND 3.5 X 16 MM WERE PLACED IN THE MID RCA. THE PATIENT RECEIVED REOPRO, HEPARIN, PLAVIX AND ASPIRIN. RESIDUAL STENOSIS WAS REDUCED FROM 100% TO 0% WITH TIMI 3 AND NO EVIDENCE OF DISSECTION. THE PATIENT WAS TRANSFERRED TO THE CCU IN STABLE CONDITION. IT WAS NOTED THAT THE PATIENT DEVELOPED CHOLECYSTITIS WHICH SUBSIDED WITH ANTIBIOTICS. THE PATIENT WAS DISCHARGED SIX DAYS POST PROCEDURE. IT WAS PLANNED THAT THE PATIENT WOULD RETURN ONE MONTH LATER FOR INTERVENTION OF THE CX AND POSSIBLY THE LAD. ABOUT THREE WEEKS LATER, THE PATIENT PRESENTED WITH DISCOMFORT OF THE LEFT PECTORAL AREA, WHICH WAS SOMEWHAT RELIEVED AFTER TWO NITROGLYCERIN TABLETS. A CATH WAS DONE ABOUT A WEEK AND A HALF LATER, WHICH SHOWED A WIDELY PATENT RCA. THE LESIONS HAD BEEN IDENTIFIED DURING THE PREVIOUS CATH. THE LESIONS IN THE CX ARTERIES WERE PREDILATED WITH A MAVERICK BALLOON AND A TAXUS EXPRESS2 2.5 X 20 MM DRUG ELUTING STENT WAS PLACED IN THE PROXIMAL TO MID PORTION OF THE MARGINAL BRANCH OF THE CX AND A TAXUS EXPRESS2 2.5 X 8 MM DRUG ELUTING STENT WAS PLACED IN THE DISTAL PORTION OF THE POSTEROLATERAL BRANCH OF THE CX. FINALLY THE LESION IN THE LAD WAS PREDILATED WITH A 2.0 X 30 MM MAVERICK BALLOON AND A TAXUS EXPRESS2 2.75 X 20 MM DRUG ELUTING STENT WAS PLACED IN THE MID LAD FOR A TOTAL OCCLUSION. ALL LESIONS HAD A REDUCTION TO 0%. NO COMPLICATIONS WERE REPORTED. APPROXIMATELY 10 MONTHS LATER, A CARDIAC CATH WAS DONE WHEN THE PATIENT PRESENTED WITH COMPLAINTS OF CHEST PAIN AND RECURRENT EXERTIONAL JAW PAIN. THE FINDINGS WERE AS FOLLOWS: THE STENT IN THE LAD HAD A FLUSH OCCLUSION WITHIN THE STENT IN THE MID PORTION. THE MID RCA HAD 50% STENOSIS, THE CX HAD MILD NON-OBSTRUCTIVE STENOSIS, HOWEVER THE STENTS IN THE RCA AND CX BRANCHES WERE PATENT. BYPASS SURGERY WAS RECOMMENDED TO TREAT THE DISTAL LAD AND MAJOR DIAGONAL BRANCH. AGGRESSIVE ANTI-PLATELET THERAPY AND BLOOD PRESSURE AND LIPID MANAGEMENT WERE ALSO RECOMMENDED. ABOUT TWO WEEKS LATER, THE PATIENT UNDERWENT CAB X 4 - IN SITU LEFT INTERNAL THORACIC ARTERY TO THE LAD AND SVG TO THE DX, OBTUSE MARGINAL AND POSTERIOR DESCENDING ARTERY. THE PATIENT WAS DISCHARGED FOUR DAYS POST SURGERY. ALMOST TWO YEARS LATER, THE PATIENT PRESENTED WITH UNSTABLE ANGINA, JAW PAIN, LIGHTHEADEDNESS, NAUSEA AND MINIMAL SHORTNESS OF BREATH. A CARDIAC CATH WAS PERFORMED WHERE AN 80% IN-STENT RESTENOSIS WAS FOUND IN THE DISTAL RCA. THE LESION WAS PREDILATED WITH A 3.0 X 15 MM MAVERICK BALLOON AND A NON-BSC STENT WAS IMPLANTED WITHIN THE OLD TAXUS STENT AND THE DISTAL RCA RESULTING IN 0% RESIDUAL STENOSIS AND TIMI 3 FLOW. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM NIQ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC 3.5X16MM

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention