ADVANTA SLIDER GDS
Received Jul 3, 2026 · Event occurred Jun 9, 2026
Report 3011175548-2026-000008 · MDR key 25704275
Device
Generic name
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Manufacturer
Atrium Medical CorporationModel number
22114Catalog number
22114
Lot number
521057
Product problems
- Material Separation
Patient
61 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING AN AVG INSERTION PROCEDURE, WHILE THE ADVANTA GRAFT WAS BEING SLOWLY PULLED INTO POSITION FOR CONNECTION BETWEEN THE ARTERY AND VEIN, THE MIDDLE SECTION OF THE GRAFT TORE. ANOTHER GRAFT WAS USED TO COMPLETE THE PROCEDURE. NO HARM WAS REPORTED.
Additional Manufacturer Narrative
DUE TO CHARACTER RESTRICTIONS IN BLOCK E1: EVENT SITE NAME: (B)(6) HOSPITAL. EVENT SITE ADDRESS: (B)(6). INITIAL REPORTER: (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.