MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT -FULLY COVERED

Model Number G52226

Device Problems Difficult to Advance (2920); Material Twisted/Bent (2981)

Patient Problem Excessive Tear Production (2235)

Event Date 01/06/2020

Event Type  Injury  

Manufacturer Narrative

Procode: esw.

Event Description

According to the initial reporter: "while placing esophageal stent, the wire was in place.When the physician went to place the stent over the wire, there was visible resistance; (b)(6), watching under fluoro, saw that stent was not moving down/advancing over the wire.Physician was having difficulty pushing stent over wire in the patient's mouth.(b)(6) (cook representative) told physician to hold, and possibly change patient position, since stent was not visible under fluoro.(b)(6) had them stop and pull it back out of patient's mouth; physician determined that the wire was the issue at this point.Physician pulled stent out, off of the wire, and all could see that wire was bent in 3 places (another manufacturer).Physician asked for another wire.Physician pulled original wire out, put scope down patient, and they could see bleeding that was not noticed by (b)(6) prior to the resistance event.(b)(6) mentioned not noticing any stricturing, physician advanced the new wire through the scope, (b)(6) asked if they could do a couple trigger pulls themselves, to simulate recapturing to make sure it worked okay--it did deploy and recapture smoothly.However, the stent was visibly kinked inside of catheter (subject of this report).Catheter was also kinked in multiple places.Physician tried to put kinked stent over the new wire and there was too much resistance.Physician asked for another stent, pulled defective stent off.Grabbed a 10cm stent and advanced it over 2nd wire.(b)(6), watching under fluoro, saw it come down smoothly and normally.(b)(6) saw physician had patient's head tilted and said it helps to "jostle" it a bit.Physician got 2nd stent in position and deployed perfectly with no issues.Inner catheter was removed, and the 2nd stent remains in the patient.This procedure was for a benign condition called persistent anastomotic leak.Because of that, generally a hemoclip would be put around the tissue in the top proximal flange of the stent to hold it in position.Physician asked for a clip.Scope was down in position and physician made comment that the patient's throat had a small tear and they would have to stitch it up.Went to place the first clip, it deployed fine.Went to place a 2nd clip, the tech pre-deployed it (another manufacturer); physician had to go in and retrieve it (retrieved successfully after multiple attempts).Physician called that portion of procedure over at that point.Physician asked for suturing devices, needles and threads to sew up tear in patient's throat.When procedure was over, physician remarked that it helps not to force the stent.(b)(6) asked if the physician believed forcing the stent caused the tear, physician affirmed that they believed it did.Physician's original intent (prior to procedure) was to leave stent in for 6 weeks, but because of placement and tear, he is not sure what he's going to do.Physician tried to see if leak was covered by stent after procedure (under x-ray); it was hard to get a conclusive image to indicate whether it was covered or not.When physician was asked by (b)(6) about their follow-up, if they would place another stent or something else, they were not sure what they would do next because of the tear and because the stent that had already been placed was place "pretty high." position of patient was laying on their back with a semi-flat pillow under their head.Unknown hemoclip (tech's first time attempting to use a clip, (b)(6) showed tech how to do it again after procedure).Tip of the flange on the 2nd stent was measured at 23cm.No kinks visible on either wire guide prior to insertion in patient, both had just been opened for that procedure.

• Brand Name: EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT -FULLY COVERED
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9611387
• MDR Text Key: 189366631
• Report Number: 3005580113-2020-00089
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002522265
• UDI-Public: (01)10827002522265(17)211017(10)C1660564
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/21/2020

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: 10/17/2021
• Device Model Number: G52226
• Device Catalogue Number: EVO-FC-20-25-12-E
• Device Lot Number: C1660564
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/21/2020
• Distributor Facility Aware Date: 01/07/2020
• Event Location: Hospital
• Date Report to Manufacturer: 01/21/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/21/2020
• Date Device Manufactured: 10/17/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention