InjuryNIO
EPIC VASCULAR SELF-EXPANDING STENT SYSTEM 8 X 80
Received Nov 12, 2019 · Event occurred Oct 3, 2019
Report 9309798 · MDR key 9309798
Device
Generic name
Stent, Iliac
Product problems
- Difficult to Remove
Patient
29565 DA
- No Code Available
- No Code Available
Narrative
Description of Event or Problem
A PATIENT HAD A WALLFLEX STENT PLACED IN THE COMMON BILE DUCT (CBD) AND AN EPIC STENT WAS BEING PLACE IN THE INTRAHEPATIC DUCT. THE EPIC STENT WAS DEPLOYED IN GOOD POSITION. AS THEY WERE RELEASING THE STENT THEY HAD DIFFICULTY RETRIEVING THE DEPLOYMENT DEVICE. ATTEMPTS WERE UNSUCCESSFUL TO REMOVE THE DEVICE, THE PATIENT RETURNED TO THE OR THE FOLLOWING DAY AND THE DEVICE WAS ULTIMATELY ABLE TO BE REMOVED.