MAUDE Adverse Event Report: ICAST STENT

Model Number 85455

Device Problems Difficult to Insert (1316); Migration or Expulsion of Device (1395); Activation Failure (3270)

Patient Problem No Information (3190)

Event Date 01/20/2015

Event Type  Injury  

Event Description

To surgery on (b)(6) 2015 for bil renal artery stenting.Upon attempt to deploy the icast stent, the device malfunctioned leaving the un-expanded stent floating in the thoracic aorta.Stent was retrieved with an ensnare through a small transverse arteriotomy made at the arterial puncture size and brought out through the brachial artery cutdown."a rosen wire was placed and, over the rosen wire a 7 mm x 22 mm icast covered stent was initially advanced but would not track over the wire into the renal artery, so the icast was withdrawn back out of the sheath and the dilator for the sheath was re-inserted and used to advanced the sheath itself into the right renal artery.The dilator was removed and the icast stent re-inserted through the sheath and positioned where i wanted it in the proximal right renal artery.The sheath was withdrawn back into the aorta and the icast balloon inflated to expand the stent, but there was no stent on the balloon.We surveyed up and down the aorta to check if somehow the stent had become dislodged inside the sheath.I was bewildered when i saw the un-expanded stent free-floating in the thoracic cavity." "the un-expanded icast stent was seen floating in the mid descending thoracic aorta.I cannot explain how the stent got to this position without withdrawing the sheath back to this level, and i cannot explain why it did not migrate distally.Using a tri-lobed snare inserted through the 7-french sheath, the free floating stent was retrieved and withdrawn back into the left brachial artery along with the sheath".

• Brand Name: ICAST STENT
• Type of Device: ICAST STENT
• MDR Report Key: 4508218
• MDR Text Key: 5439176
• Report Number: 4508218
• Device Sequence Number: 1
• Product Code: JCT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Model Number: 85455
• Device Lot Number: 22057187
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/22/2015
• Distributor Facility Aware Date: 01/20/2015
• Event Location: Hospital
• Date Report to Manufacturer: 01/22/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/26/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 116