BEUDAMED
    FDA Adverse Event Death Summary report: N

    VISI-PRO BALLOON-EXPANDABLE STENT SYSTEM

    MDR report key: 6868092 · Received September 15, 2017

    Report

    Report Number
    2183870-2017-00399
    Event Type
    Death
    Date Received
    September 15, 2017
    Date of Event
    March 29, 2017
    Report Date
    August 17, 2017
    Manufacturer
    COVIDIEN
    Product Code
    FGE
    PMA / PMN Number
    K061566
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH: MEAN AGE. SEX: MEAN GENDER. DATE OF EVENT: DATE ARTICLE PUBLISHED. STUDY TITLE: SIMULTANEOUS VERTEBRAL AND SUBCLAVIAN ARTERY STENTING DAMIAN R. MACIEJEWSKI, LUKASZ TEKIELI, ROMAN MACHNIK , ANNA KABLAK-ZIEMBICKA , TADEUSZ PRZEWLOCKI, PIOTR PALUSZEK, MARIUSZ TRYSTULA , ROBERT MUSIAL, KAROLINA DZIERWA, PIOTR PIENIAZEK ADV INTERV CARDIOL 2017; 13, 2 (48): 142¿149 DOI: HTTPS://DOI.ORG/10.5114/PWKI.2017.68052. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IN A JOURNAL ARTICLE AIMING TO EVALUATE THE SAFETY AND EFFICACY OF SIMULTANEOUS ANGIOPLASTY OF VERTEBRAL AND SUBCLAVIAN STENOSIS, 15 PATIENTS WITH AN AVERAGE AGE OF 69.5 YEARS AND A MEAN GENDER OF 46.7 % MALE WERE SCHEDULED FOR SIMULTANEOUS SA/VA (SUBCLAVIAN ARTERY / VERTEBRAL ARTERY) ANGIOPLASTY BETWEEN 2007 <(>&<)> 2015. DURING THE PROCEDURES, SUBCLAVIAN ARTERY STENOSIS WAS TREATED WITH VARIOUS BRANDS OF STENTS INCLUDING VISI-PRO, WHILE VERTEBRAL ARTERY STENOSIS WAS TREAT WITH BRANDS OF STENTS INCLUDING BMS VOLO, BMS SKYLOR, DES ENDEAVOR RESOLUTE RX, DES ENDEAVOR, DES RESOLUTE INTEGRITY DEVICES. STUDY PARTICIPANTS WERE EVALUATED AT 1, 6 AND 12 MONTHS AND THEN AT YEARLY INTERVALS AFTER PROCEDURE. NO PERIPROCEDURAL DEATH, STROKE, MYOCARDIAL INFRACTION OR TRANSIENT ISCHEMIC ATTACK OCCURRED. DURING FOLLOW UP, 2 OUT OF 3 PATIENTS WITH RECURRENT SYMPTOMS, CRITICAL RESTENOSIS WAS REVEALED WHICH WAS LATER SUCCESSFULLY REDILATED WITH DEB. LEFT VA IN-STENT RESTENOSIS OCCURRED IN ONE PATIENT. IN-STENT OCCLUSION OF THE VA WAS REVEALED IN 2 CASES. DURING THE FIRST FOLLOW UP, 3 DEATHS WERE RECORDED, THE FIRST DUE TO KIDNEY FAILURE, THE SECOND DUE TO MYOCARDIAL INFRACTION AND THE THIRD DUE TO LIVER CANCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649142 VISI-PRO BALLOON-EXPANDABLE STENT SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death