BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 3851613 · Received June 5, 2014

    Report

    Report Number
    2134265-2014-03015
    Event Type
    Death
    Date Received
    June 5, 2014
    Date of Event
    September 3, 2013
    Report Date
    May 8, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT . DEVICE EVALUATED BY MFR: IT IS 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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, THE PATIENT EXPIRED. IN (B)(6) 2009, THE PATIENT WAS TAKEN TO THE HOSPITAL DUE TO ACUTE MYOCARDIAL INFARCTION. A 100% STENOSED DE NOVO LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (PROX LAD) WAS TREATED WITH PLACEMENT OF A NON-BSC STENT. A 100% STENOSED DE NOVO LESION IN THE DISTAL RIGHT CORONARY ARTERY (DIST RCA) WAS TREATED WITH ANOTHER SAME TYPE OF NON-BSC STENT. A 99% STENOSED DE NOVO LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (PROX RCA) WAS TREATED WITH A TAXUS LIBERTE STENT. RESIDUAL STENOSIS WAS 0% FOR ALL LESIONS, AND TIMI FLOW IMPROVED FROM 0 TO 3. INTRAVASCULAR ULTRASOUND WAS NOT PERFORMED. THE BLOOD FLOW WAS IMPROVED FOR BOTH BRANCHES, BUT THE PATIENT WENT INTO CARDIOGENIC SHOCK DURING THE PROCEDURE. INTRA-AORTIC BALLOON PUMP (IABP) WAS DEPLOYED AND THE PATIENT WAS TREATED WITH MEDICATION. IN (B)(6) 2009, A URETHRAL CATHETER WAS STRETCHED BY BODY MOTION AND IT DAMAGED URETHRA, RESULTING IN BLEEDING. A COUPLE DAYS LATER, THE PATIENT STOPPED TAKING ASPIRIN FOR THE TREATMENT OF URETHRAL BLEEDING. AFTER TREATMENT THE PATIENT WAS DISCHARGED AND THE FOLLOW-UP CARE HAD BEEN PERFORMED AT ANOTHER HOSPITAL. IN (B)(6) 2011, A FOLLOW-UP WAS PERFORMED. IT WAS CONFIRMED THAT THE PATIENT HAD NO ANGINA SYMPTOM AND HAD BEEN ON A STABLE DOSE OF TICLOPIDINE AND STOPPED TAKING CLOPIDOGREL. IN (B)(6) 2012, A FOLLOW-UP WAS PERFORMED. IT WAS CONFIRMED THAT THE PATIENT HAD NO ANGINA SYMPTOM AND HAD BEEN ON A STABLE DOSE OF TICLOPIDINE. IN (B)(6) 2013, THE PATIENT WAS TAKEN TO THE HOSPITAL DUE TO RESPIRATORY DISCOMFORT AND DECREASED LEVEL OF CONSCIOUSNESS. CONGESTION WAS CONFIRMED UNDER X-RAY. THE PATIENT WAS DIAGNOSED WITH CONGESTIVE HEART FAILURE AND WAS HOSPITALIZED. NON-INVASIVE POSITIVE PRESSURE VENTILATION(NIPPV) WAS PUT AND EMULGENT WAS ADMINISTERED. A URETHRAL BALLOON WAS INSERTED. HEMATURIA AND COAGULANT WERE CONFIRMED. THE URETHRAL BALLOON WAS REMOVED 9 DAYS LATER. SINCE EMICTION WAS NOT CONFIRMED, URETHRAL CATHETERIZATION WAS PERFORMED. AT THAT TIME, HEMATURIA WAS CONFIRMED AGAIN. IN (B)(6) 2013, THE PATIENT WAS SEEN IN THE UROLOGY DEPARTMENT AND IT WAS FOUND THE ENLARGED PROSTATE GOT WORSE. A URETHRAL BALLOON WAS DEPLOYED. ANTIBIOTIC WAS ADMINISTERED DUE TO SEVERE INFLAMMATION REACTION. THE PATIENT WAS DISCHARGED AND CHANGED HOSPITAL. IN (B)(6) 2013, THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328470 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY UNK433

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Death 2 ENDEAVOR STENTS