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

Catalog Number UNKNOWN

Device Problem Partial Blockage (1065)

Patient Problem Obstruction/Occlusion (2422)

Event Date 10/01/2020

Event Type  Injury  

Manufacturer Narrative

Mum stent, metalic expandable, duodenal.

Event Description

Ge et al 2020 (evo-d) ¿ ¿eus-guided gastroenterostomy versus enteral stent placement for palliation of malignant gastric outlet obstruction¿.The procedure was performed using a therapeutic gastroscope (gif-xtq160; olympus america, center valley, pa).Once the area of stenosis was reached endoscopically, a standard cannula (tandem xl; boston scientific, marlborough, ma) with 0.035 inch guidewire was advanced across the obstruction.Contrast was injected to delineate the length of the stenosis.An appropriately sized uncovered metal duodenal stent (wallflex duodenal; boston scientific, or evolution; cook medical, bloomington, in) was then deployed under direct endoscopic and fluoroscopic guidance across the stenosis." stent-related biliary obstruction (2.1% of 97).

• Brand Name: EVOLUTION DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 11310999
• MDR Text Key: 231310399
• Report Number: 3005580113-2021-00024
• 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: 02/10/2021

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
• Distributor Facility Aware Date: 01/29/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/10/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/10/2021
• 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
• Patient Age: 66 YR