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

Catalog Number EVO-FC-20-25-10-E

Device Problem Migration (4003)

Patient Problem Peritonitis (2252)

Event Date 11/30/2019

Event Type  Injury  

Manufacturer Narrative

Common name; pro code: esw.

Event Description

Per journal article: "vedantum et al 2020 evolution (20 mm × 25 mm × 10 cm) endoscopic stents in the management of bariatric complications: our algorithm and outcomes.Stent migration which led to peritonitis: in the rygb subgroup, there was one patient that required reoperation for a complication directly related to the stent.The patient had a vertical banded gastroplasty converted to rygb, and she then developed a perforation at the gastrojejunostomy which was successfully managed with a stent.The stent was removed after the perforation healed, but her stricture recurred.This was managed again with a stent, which unfortunately migrated to the small bowel anastomosis where it became impacted and eroded through the wall of the bowel.This led to peritonitis requiring exploratory laparotomy with stent retrieval via resection and reconstruction of her gastric bypass.This file will capture 1 case of stent migration which lead to peritonitis requiring laparotomy with stent retrieval.Rpn used: please note as stated in the paper: 'fully covered self-expandable metallic stents were used exclusively.Based on institutional availability, either cook evolution (20 mm × 25 mm × 10 cm) or boston scientific wallflex (23 mm × 28 mm × 12.5 cm or 23 mm × 28 mm × 15.5 cm) fully covered esophageal stents were used.' it cannot be confirmed of the overall 51 stents placed across a cohort of 35 patients, which were cook stents, this file is created to capture the potential that it could have been a cook evolution stent.

• Brand Name: EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT -FULLY COVERED
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 10402348
• MDR Text Key: 203352399
• Report Number: 3005580113-2020-00394
• Device Sequence Number: 1
• Product Code: ESW
• 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: 08/13/2020

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 Catalogue Number: EVO-FC-20-25-10-E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/16/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/13/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2020
• 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