EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED
Received Jun 10, 2026 · Event occurred May 13, 2026
Report 3001845648-2026-00225 · MDR key 25462114
Device
Generic name
Mqr - Stent, Colonic, Metallic, Expandable
Manufacturer
Cook Ireland LtdModel number
G48028Catalog number
EVO-25-30-8-C
Lot number
C2367985
Product problems
- Activation Failure
Patient
63 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE STENT DELIVERY SYSTEM PASSED THROUGH THE ENDOSCOPIC WORKING CHANNEL AND REACHED THE LOCATION OF THE OBSTRUCTION IN THE SIGMOID COLON. USER ADVANCED SYSTEM THE STENOSIS AND RELEASED THE STENT. HOWEVER, IT WAS FOUND THAT THE STENT COULD NOT BE RELEASED. THE SAFETY WIRE WAS REMOVED, BUT THE STENT STILL COULD NOT BE RELEASED. SUBSEQUENTLY, IT WAS WITHDRAWN FROM THE BODY AND REPLACED WITH A NEW ONE TO SUCCESSFULLY COMPLETE THE PROCEDURE.
Additional Manufacturer Narrative
D9. DEVICE RECEIVED BUT REMAINS UNDER INVESTIGATION. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.