BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 6002601 · Received October 6, 2016

    Report

    Report Number
    2134265-2016-09141
    Event Type
    Death
    Date Received
    October 6, 2016
    Report Date
    September 7, 2016
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. LITERATURE CITATION: IGAWA, M. ET AL. (2016). A CASE OF VERY LATE STENT THROMBOSIS SIX YEARS AFTER PACLITAXEL-ELUTING STENT IMPLANTATION DURING CANCER CHEMOTHERAPY WITH BEVACIZUMAB. HEART ORIGINAL 48:5. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. 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. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #: 2134265-2016-09139, 2134265-2016-09140. IT WAS REPORTED VIA A JOURNAL ARTICLE THAT A DISSECTION OCCURRED. IN 2008 THE PATIENT PRESENTED WITH ACUTE INFERIOR MYOCARDIAL INFARCTION AND UNDERWENT IMPLANTATION OF A BARE METAL STENT (LIBERTÉ®) INTO THE RIGHT CORONARY ARTERY CULPRIT SITE IN THE ACUTE STAGE. ANGIOGRAPHY AT THIS TIME ALSO REVEALED 90% STENOSIS IN THE CIRCUMFLEX BRANCH AND PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS ADDITIONALLY PERFORMED FOR THE SITE IN THE CHRONIC STAGE. WHEN THE FIRST TAXUS EXPRESS2 DRUG ELUTING STENT (2.5/12 MM) WAS PLACED, DISSECTION WAS OBSERVED AT THE DISTAL END AND AN ADDITIONAL TAXUS EXPRESS2 STENT (2.75/12 MM) WAS PLACED ADJACENT TO THE DISTAL END OF THE FIRST STENT. BECAUSE OF A LACK OF STENT STOCKS, A LARGER DIAMETER STENT WAS PLACED AT THE PERIPHERAL SIDE. THE STENT AT THE PERIPHERAL SIDE WAS OVERSIZED AND PLACED AT AN INFLATION PRESSURE OF 6 ATM, LOWER THAN THE NOMINAL INFLATION PRESSURE (9 ATM). THE DISSECTION DISAPPEARED ON ANGIOGRAPHY AND THE PROCEDURE WAS TERMINATED (FIGURE 1), BUT IT WAS NOT CONFIRMED BY INTRAVASCULAR ULTRASOUND. FOLLOW-UP ANGIOGRAPHY AFTER 1 YEAR SHOWED NO RESTENOSIS FOR BOTH STENT SITES AND ASPIRIN AND CLOPIDOGREL WERE CONTINUED. THE PATIENT DEVELOPED CECAL CANCER AND UNDERWENT COLECTOMY IN 2013. IT WAS NON-CURATIVE RESECTION AND CLOPIDOGREL WAS DISCONTINUED AFTER THE SURGERY. THE PATIENT CONTINUED ONLY ASPIRIN (100 MG/DAY). THE PATIENT WAS FOUND TO HAVE PERITONEAL DISSEMINATION, INTESTINAL OBSTRUCTION, AND MULTIPLE LUNG METASTASES AND RECEIVED CANCER CHEMOTHERAPY IN 2014. TWENTY DAYS AFTER THE ADMINISTRATION, THE PATIENT SUDDENLY HAD CHEST PAIN AND CALLED AN AMBULANCE. THE PATIENT WAS NOTED TO HAVE CLEAR CONSCIOUSNESS, BLOOD PRESSURE 86/54 MMHG, PULSE RATE 90 BPM, BODY TEMPERATURE 35.5ºC, PERIPHERAL COLDNESS, CLEAR LUNG SOUNDS, NO CARDIAC MURMUR, AND NO EDEMA OF THE LOWER EXTREMITIES. ACCORDING TO THE VARIOUS TEST RESULTS INCLUDING THE ECG FINDINGS THAT HAD GREATLY CHANGED FROM THOSE BEFORE THE CHEMOTHERAPY, ACUTE MYOCARDIAL INFARCTION WAS DIAGNOSED. REPORTEDLY, THE PATIENT HAD 3 MONTHS TO LIVE AT THE SHORTEST DUE TO THE CANCER, BUT THE SYMPTOMS WERE SEVERE AND IT WAS DETERMINED THAT IF THE PATIENT COULD UNDERGO A SHORT-TIME PROCEDURE, IT WOULD RESULT IN IMPROVEMENT OF THE QUALITY OF LIFE. THEN, EMERGENCY CORONARY ANGIOGRAPHY WAS PERFORMED. THE LEFT CIRCUMFLEX BRANCH HAD THROMBOTIC OCCLUSION AT THE SITE OF TAXUS EXPRESS2 PLACEMENT. COLLATERAL CIRCULATION WAS NOT OBSERVED AND A DIAGNOSIS OF VERY LATE STENT THROMBOSIS AT THE SITE OF THE TAXUS EXPRESS2 STENT PLACEMENT WAS MADE. INTERVENTION WAS ATTEMPTED, BUT IT WAS DIFFICULT TO MAINTAIN THE BLOOD PRESSURE EVEN WITH USE OF CATECHOLAMINE. IN GENERAL, AORTIC BALLOON PUMPING WAS INDICATED, BUT THE PATIENT HAD SEVERE ARTERIOSCLEROSIS OBLITERANS AND IT WAS EXPECTED THAT AN ISCHEMIC EVENT OF THE LOWER EXTREMITY WOULD DEFINITELY OCCUR IF A CATHETER WAS INSERTED FROM THE GROIN. THE DISEASE CONDITION WAS EXPLAINED TO HER FAMILY AND CONSERVATIVE TREATMENT WAS SELECTED. AFTER RETURNING TO THE ROOM, ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE PROGRESSED TO SUSTAINED MONOMORPHIC VENTRICULAR TACHYCARDIA AND IT WAS TERMINATED WITH DIRECT-CURRENT DEFIBRILLATOR. THIS FURTHER MADE IT DIFFICULT TO MAINTAIN THE BLOOD PRESSURE AND THE PATIENT DIED ABOUT 12 HOURS AFTER THE EVENT ONSET ON THE DAY OF ADMISSION. AUTOPSY COULD NOT BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655153 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493800112270

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death| R