BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1081445 · Received July 25, 2008

    Report

    Report Number
    2134265-2008-02093
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    April 24, 2006
    Report Date
    July 10, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    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 COMPLAINANT INDICATED THAT 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 INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME CASE AS MFR. # 2134265-2008-02092, 2134265-2008-02094, 2134265-2008-02095 AND 2134265-2008-02096. IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT THROMBOSIS AND SUBSEQUENT CORONARY ARTERY BYPASS GRAFTING OCCURRED. THE TARGET LESION WAS LOCATED IN THE 75% STENOSED PROXIMAL AND 90% STENOSED MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.5X20MM TAXUS EXPRESS2 (TE2) DRUG ELUTING STENT WAS DEPLOYED AT 16 ATM IN THE MID LAD. A 2.0X15MM MAVERICK BALLOON WAS INFLATED TO 12 ATM. A 3.5X12MM TE2 STENT WAS THEN ADVANCED IN THE PROXIMAL LAD, BUT WAS UNABLE TO CROSS THE LESION. SUBSEQUENTLY THE LESION WAS DILATED USING A 2.0X15MM MAVERICK BALLOON AND A THEN A 2.5X12MM TE2 STENT WAS ADVANCED AND DEPLOYED AT 18 ATM. POST PROCEDURE STENOSIS WAS 0% WITH TIMI FLOW 3. MEDICATIONS RECEIVED DURING THE PROCEDURE INCLUDED NITROGLYCERIN. THERE WERE NO PATIENT COMPLICATIONS. NINE MONTHS LATER THE PATIENT PRESENTED WITH CHEST PAIN. ANGIOGRAPHY REVEALED TOTAL OCCLUSION OF THE LAD NEAR THE OSTIUM. A 2.5X20MM BALLOON (UNSPECIFIED TYPE) WAS ADVANCED IN THE DISTAL LAD AND MULTIPLE INFLATIONS WERE PERFORMED THROUGH THE ENTIRE PROXIMAL STENTED SEGMENT AND NON STENTED SEGMENT ALL THE WAY TO THE OSTIUM, WHICH CREATED TIMI 2.5 FLOW WITH SOME ELEMENT OF THROMBUS PRESENT AND A DISSECTION NOTED. A 3.0X 32 MM TE2 STENT WAS DEPLOYED AT 16 ATM IN THE MID-SEGMENT, COVERING THE PREVIOUSLY STENTED DISTAL AREA. IN AN OVERLAPPING FASHION, A 3.5X28MM TE2 WAS THEN DEPLOYED AT 12 ATM MORE PROXIMALLY WITH EXCELLENT ANGIOGRAPHIC RESULTS. TIMI 3 FLOW WAS NOTED. THERE WAS LOSS OF A SMALL TO MODERATE SIZED DIAGONAL BRANCH. DURING THE PROCEDURE THE PATIENT HAD SIGNIFICANT IDIOVENTRICULAR RHYTHMS. A TEMPORARY PACEMAKER WAS INSERTED FOR PROPHYLACTIC STANDBY. AN INTRA-AORTIC BALLOON PUMP WAS INITIATED WITH 1:1 COUNTER-PULSATION. NO ADDITIONAL INFORMATION WAS PROVIDED INDICATING SUBSEQUENT HOSPITAL COURSE AND DISCHARGE. TWO WEEKS LATER, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH CHEST PAIN. EKG SHOWED AN OLD ANTEROLATERAL WALL INFARCT PATTERN. THE PATIENT'S CARDIAC ENZYMES WERE ELEVATED. ANGIOGRAM REVEALED 100% OCCLUSION OF THE MID LAD AT THE SITE OF THE STENT. A 2.5 X 20 MM MAVERICK BALLOON WAS INTRODUCED AND MULTIPLE INFLATIONS WERE PERFORMED. THE INFLATIONS WERE DIFFICULT DUE TO THE TORTUOSITY OF THE MID LAD. A 3.0 X 28 MM TE2 STENT WAS DEPLOYED AT 15 ATM FOR 40 SECONDS AT THE PREVIOUSLY STENTED AREA. GOOD ANGIOGRAPHIC RESULTS WERE NOTED. THE PATIENT RECEIVED INTEGRILIN DURING THE PROCEDURE. SIX MONTHS LATER, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH UNSTABLE ANGINA AND WAS ANTICOAGULATED. THE 90% STENOSED DIAGONAL BRANCH WAS STENTED (UNSPECIFIED STENT) AND A 2.5X20MM MAVERICK BALLOON WAS INFLATED ONCE. ANGIOGRAM SHOWED 0% RESIDUAL STENOSIS WITH TIMI 3 FLOW, NO DISSECTION AND NO THROMBUS. ATTEMPTS AT CROSSING THE 100% STENOSED LESION IN THE MID LAD WITH A NON BSC GUIDE WIRE WERE UNSUCCESSFUL AND THE PROCEDURE WAS COMPLETED. SIX DAYS LATER, THE PATIENT HAD CORONARY ARTERY BYPASS GRAFTING TIMES TWO VESSELS; A LEFT INTERNAL MAMMARY ARTERY TO THE LAD AND A SAPHENOUS VEIN GRAFT TO THE DIAGONAL. FOLLOWING SURGERY THE PATIENT WAS BROUGHT TO THE ICU IN GOOD CONDITION. THROUGHOUT THE COURSE OF PATIENT TREATMENT THE PATIENT HAS BEEN TAKING PLAVIX AND ASPIRIN. NO ADDITIONAL INFO WAS PROVIDED.

    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 CORPORATION 2.5X12MM

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention