inforMED
MalfunctionQCA

UNKNOWN_NEUROVASCULAR_PRODUCT

Received Jun 24, 2026 · Event occurred Jun 2, 2026

Report 3008881809-2026-00396 · MDR key 25611874

Device

Generic name

Intracranial Coil-assist Stent

Catalog number

UNK_NEU

Product problems

  • Entrapment of Device
  • Migration

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THAT DURING PROCEDURE THE SUBJECT STENT DELIVERY WIRE CAUGHT ON STENT TINES AFTER DEPLOYMENT. THE PHYSICIAN COULD SEE PROXIMAL STENT TINES MOVING WITH DELIVERY WIRE. ANATOMICALLY, THE CASE WAS VERY CHALLENGING, AND THE STENT WAS NOT ABLE TO BE RE-ACCESSED AFTER THE DELIVERY WIRE WAS FREED. MICROCATHETER WAS TRACKED UP AND USED IT TO HELP PUSH THE WIRE FREE (THROUGH SOME RESISTANCE). PROCEDURE WAS NOT COMPLETED SUCCESSFULLY ON THE SAME DAY AS AFTER MANY HOURS OF TRYING DIFFERENT THINGS THE PHYSICIAN CALLED IT A DAY. HE BROUGHT THE PATIENT BACK FIRST THING THE NEXT MORNING THOUGH AND WAS ABLE TO SUCCESSFULLY FINISH THE CASE. IT WAS STATED THAT IT WOULD BE DIFFICULT TO TELL IF THAT WAS THE ISSUE WITH THE SUBJECT DEVICE OR IF IT WAS JUST THE EXTREME ANGLE OF THE A1 TAKEOFF.