BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 922677 · Received October 3, 2007

    Report

    Report Number
    6000089-2007-01384
    Event Type
    Injury
    Date Received
    October 3, 2007
    Date of Event
    June 9, 2007
    Report Date
    September 6, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A UNIT HAS NOT BEEN RETURNED FOR REVIEW, THEREFORE, A TECHNICIAN ANALYSIS CANNOT BE CARRIED OUT. WITHOUT A RETURNED UNIT, IT IS NOT POSSIBLE TO CONFIRM HOW THE DEVICE MAY HAVE CONTRIBUTED TO THE COMPLAINT INCIDENT. A REVIEW OF THE MANUFACTURING RECORD FOR THIS PARTICULAR BATCH # 7830115 SHOWS THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS AT THE TIME OF ITS RELEASE TO DISTRIBUTION. THE ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    CLINICAL TRIAL. SAME CASE AS MFR# 6000093-2007-01847. IT WAS REPORTED THAT POST INDEX PROCEDURE, THE PATIENT HAD A MYOCARDIAL INFARCTION (MI), STENT THROMBOSIS (ST) AND A TARGET VESSEL REVASCULARIZATION (TVR). THE PATIENT PRESENTED TO THE INDEX PROCEDURE WITH ANGINA. THE TARGET LESION WAS LOCATED IN THE PROX CIRCUMFLEX (CX) WITH 95% STENOSIS AND WAS 18 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.3 MM. THE TARGET LESION WAS TREATED WITH PRE-DILATION AND A 2.25 X 24 MM TAXUS LIBERTE STENT WAS IMPLANTED. POST-DILATATION WAS PERFORMED WITH 0% RESIDUAL STENOSIS. THE PATIENT HAD A NON-TARGET LESION LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA) ALSO. THE LESION WAS 2.5 MM WIDE, 40 MM LONG, AND 95% STENOSED. THE LESION WAS STENTED WITH 2 TAXUS EXPRESS2 STENTS: A 2.5 X 24 MM AS WELL AS A 2.75 X 28 MM. CLINICAL ANGIOGRAPHIC SUCCESS WAS REPORTED IN THE TREATMENT OF THE NON-TARGET LESION. THE PATIENT WAS DISCHARGED ONE DAY LATER ON PROTOCOL DOSES OF ASPIRIN AND PLAVIX. ON DAY 620, THE PATIENT PRESENTED WITH CHEST PAIN. ECG REVEALED 4 MM ST ELEVATION IN THE INFERIOR LEADS WITH RECIPROCAL CHANGES IN THE PRECORDIUM. THE PATIENT WAS TREATED WITH ASPIRIN AND NITROGLYCERIN. HE DEVELOPED BRADYCARDIA AND HYPOTENSION AND WAS TRANSFERRED FOR CARDIAC CATHETERIZATION. IT WAS NOTED THAT THE PATIENT STOPPED PLAVIX IN 2006. THE CATHETERIZATION REPORT NOTED "CARDIOGENIC SHOCK WITH BRADYCARDIA AND SIMULTANEOUS OCCLUSION OF THE CX AND RCA, REPRESENTING IN-STENT THROMBOSIS." THE PATIENT UNDERWENT BALLOON ANGIOPLASTY IN THE PROX CX AND TIMI 3 FLOW WAS ESTABLISHED WITH A 0% RESIDUAL STENOSIS IN THE AREA OF THE THROMBOSIS. THE PATIENT CONTINUED TO EXPERIENCE CHEST PAIN AND ST ELEVATION. HE THEN UNDERWENT ASPIRATION THROMBECTOMY IN THE RCA AND BALLOON ANGIOPLASTY. TIMI 3 FLOW IN THE DISTAL RCA WAS ESTABLISHED WITH A 0% RESIDUAL STENOSIS. THE POSTERO-LATERAL ASPECT OF THE RCA REMAINED DIFFUSELY DISEASED AT 50% OR GREATER. THERE WAS ALSO A 100% STENOSIS IN THE PROX CX WITH THE PRESENCE OF THROMBUS. THE PATIENT WAS STARTED ON HEPARIN AND ABCIXIMAB. AN INTRA-AORTIC BALLOON PUMP WAS INSERTED AFTER HIS HYPOTENSION DID NOT RESPOND TO DOPAMINE AND PHENYLEPHRINE HYDROCHLORIDE. A TEMPORARY TRANSVENOUS PACEMAKER WAS PLACED AS TREATMENT FOR PERSISTENT SYMPTOMATIC BRADYCARDIA WHICH WAS REFRACTORY TO ATROPINE TREATMENT. THE PERSISTENT HYPOTENSION WAS THOUGHT TO BE POSSIBLY RELATED TO THE ADMINISTRATION OF TADALAFIL AND NITROGLYCERIN WHICH WAS NOTED IN THE CATHETERIZATION REPORT. THE INTRA-AORTIC BALLOON PUMP AND DOPAMINE WERE DISCONTINUED THE NEXT DAY. THE PATIENT WAS DISCHARGED 2 DAYS LATER ON ASPIRIN AND PLAVIX. IN THE OPINION OF THE PHYSICIAN, THERE IS A POSSIBLE RELATIONSHIP BETWEEN THE EVENTS AND THE STENTS. IN 2007, THE CLINICAL EVENTS COMMITTEE CONFIRMED ALL EVENTS AS WELL AS A POSSIBLE RELATIONSHIP BETWEEN THE EVENTS AND THE STENTS.

    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 CORP. 2.5 X 24 MM 7830115

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| R