BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTÉGÉ GPS SELF-EXPANDING PERIPHERAL STENT SYSTEM

    MDR report key: 6383340 · Received March 7, 2017

    Report

    Report Number
    2183870-2017-00108
    Event Type
    Injury
    Date Received
    March 7, 2017
    Date of Event
    January 1, 2011
    Report Date
    February 6, 2017
    Manufacturer
    COVIDIEN
    Product Code
    NIO
    PMA / PMN Number
    P060001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE: HUANG, Y., ET AL. (2016). "THE FEASIBILITY AND SAFETY OF A THROUGH-AND-THROUGH WIRE TECHNIQUE FOR CENTRAL VENOUS OCCLUSION IN DIALYSIS PATIENTS." BMC CARDIOVASCULAR DISORDERS 16(1). DOI 10.1186/S12872-016-0411-3. MAJORITY GENDER CINE IMAGE REVIEW: THE ARTICLE INCLUDED THREE SERIES OF CINE IMAGES THAT ILLUSTRATE THE PROCEDURES USED. THE ARTICLE DID NOT INDICATE WHICH BRANDS OF STENTS WERE INVOLVED WITH THE CINE SERIES. DUE TO THE QUALITY AND CLARITY OF THE CINE IMAGES IN THE ARTICLE POSITIVE IDENTIFICATION OF THE STENTS IN THE CINE IMAGES COULD NOT BE PERFORMED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A STUDY WAS CARRIED OUT BETWEEN JAN 2011 AND DEC 2015 TO EXAMINE THE FEASIBILITY AND SAFETY OF A THROUGH-AND-THROUGH WIRE TECHNIQUE FOR CENTRAL VENOUS OCCLUSION IN DIALYSIS PATIENTS. A TOTAL OF 49 PATIENTS WERE EXAMINED IN THE STUDY (28 MALES AND 21 FEMALES; MEAN AGE 56.5 YEARS, AGE RANGE 29¿81 YEARS). EIGHTEEN PROTEGE STENTS WERE USED IN THIS STUDY. THE LENGTH OF EACH STENT WAS 10¿20 MM LONGER THAN THE LESION, AND ITS DIAMETER WAS 10%¿20% LARGER THAN THAT OF THE ADJACENT NON-AFFECTED VEIN. THE CUT-OFF VALUE FOR THE LESION LENGTH WAS 6.5 CM. DURING ONE MONTH FOLLOW UP PATIENTS PRESENTED WITH POST-OPERATIVE COMPLICATIONS; HEMATOMA AT PUNCTURE POSITION (2 PATIENTS), THROMBUS AND DYSFUNCTION OF ACCESS (2 PATIENTS), ACUTE HEART FAILURE (2 PATIENT) AND ACUTE PERICARDIAL EFFUSION (1 PATIENT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166412 PROTÉGÉ GPS SELF-EXPANDING PERIPHERAL STENT SYSTEM STENT, ILIAC NIO COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization