MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Type  Injury  

Manufacturer Narrative

Mum stent, metalic expandable, duodenal.

Event Description

Jang et al 2019 ¿superiority of gastrojejunostomy over endoscopic stenting for palliation of malignant gastric outlet obstruction.A retrospective cohort study was conducted from the registries of patients who received endoscopic duodenal sems placement andwho underwent gj for the palliation of malignant goo at the cleveland clinic between 2011 and 2017.For endoscopic stenting, uncovered, duodenal sems, either wallflex duodenal stent (boston scientific, (b)(4)) or evolution duodenal stent (cook medical, (b)(4)), was placed under endoscopic and fluoroscopic guidance.183 patients with enteral stenting and 127 with gj were included in the study.The complications of endoscopic stenting included perforation (5 cases).

• Brand Name: EVOLUTION DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 11327258
• MDR Text Key: 239457350
• Report Number: 3005580113-2021-00027
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/15/2021

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• 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: 02/15/2021
• Distributor Facility Aware Date: 02/01/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/11/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR