inforMED
InjuryMZY

SLIDER EASY GLIDE SYSTEM

Received Mar 26, 2020

Report 3011175548-2020-00459 · MDR key 9886941

Device

Generic name

Graft, Vascular, Stainless Steel Tunneler

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

Not reported

  • Hematoma
  • Unspecified Infection
  • Occlusion
  • Seroma
  • Thrombosis
  • Hematoma
  • Unspecified Infection
  • Occlusion
  • Seroma
  • Thrombosis

Narrative

Additional Manufacturer Narrative

WE ARE UNABLE TO FULLY INVESTIGATE THIS REPORT AS NO PRODUCT NUMBER, LOT NUMBER OR SAMPLE WAS PROVIDED. IT IS NOT KNOWN WHAT RELATIONSHIP THE FLIXENE HAS TO THE REPORTED ADVERSE EVENTS. THE ARTICLE FOUND THE USE OF THE EARLY CANNULATION GRAFT FLIXENE TO BE SAFE WITH A LOW COMPLICATION RATE AND FAVOURABLE PATENCY RATES. BASED ON THE INFORMATION AVAILABLE ATRIUM HAS DETERMINED THAT THE EVENTS DESCRIBED ARE NOT RELATED TO A PRODUCT FAILURE.

Description of Event or Problem

RECEIVED AN ARTICLE TITLED SINGLE-CENTRE EXPERIENCE OF AN EARLY CANNULATION GRAFT FOR HAEMODIALYSIS ACCESS. PURPOSE: THIS ARTICLE REPORTS ON THE OUTCOMES FROM THE LARGEST SERIES TO DATE USING THE EARLY CANNULATION GRAFT FLIXENE IN A SINGLE CENTRE. METHOD: BETWEEN MAY 2012 AND MARCH 2018, 141 FLIXENE GRAFTS WERE PLACED FOR DIALYSIS ACCESS. THE OUTCOMES OF THE ARTERIOVENOUS GRAFTS WERE REVIEWED RETROSPECTIVELY FROM ELECTRONICALLY HELD RECORDS AND IMAGING. PER THE ARTICLE ADVERSE EVENTS INCLUDED GRAFT INFECTION, OCCLUSION (STEAL SYNDROME) HEMATOMA, SEROMA AND THROMBOSIS.