MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED; MUM STENT, METALIC EXPANDABLE, DUODENAL

Catalog Number UNKNOWN

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

Patient Problem Aspiration Pneumonitis (4455)

Event Date 06/13/2022

Event Type  Injury  

Event Description

Takamatsu 2022, the glasgow prognostic score and stricture site can predict prognosis after endoscopic duodenal stent placement for malignant gastric outlet obstruction.Endoscopic ds placements were performed under conscious sedation induced by an intravenous injection of midazolam and/or pentazocine.A lateral-viewing duodenal endoscope (tjf-260v, olympus medical systems, tokyo, japan) or a forward-viewing gastrointestinal endoscope (cf-h260ai, olympus medical systems, tokyo, japan) was used according to the site of the stricture.First, an endoscope was inserted at the proximal site of stenosis with a catheter, and a guidewire passed through the stricture.After confirming the site and length of duodenal stenosis with a contrast medium, the ds was deployed across the stricture under endoscopic and fluoroscopic guidance.According to the site and length of a stricture, a wallflex ds (6, 9, or 12cm in length, 22mm in body diameter; boston scientific, marlborough, ma, united states), niti-s ds (uncovered type 6, 8, 10, or 12cm in length, covered type 8 or 10cm in length, 22mm in body diameter; taewoong medical, seoul, korea) or evolution ds (6, 9, or 12cm in length, 22mm in body diameter; cook medical, winston-salem, nc, united states) was selected based on the endoscopist¿s preference.Evolution, which were all uncovered type, were used in 25 patients.This file will capture 4 patients that were recorded as having cholangitis and 1 patient that had aspiration pneumoniae as a procedure related complication.E.Require intervention/additional procedures s=4.80 male and 55 female patients average age 72 years.

Manufacturer Narrative

Pma/510(k) # k163468.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Supplemental report is being submitted as file to be cancelled following review of supplemental table available through the doi link, the evo device didn¿t contribute to any procedure related complications.Takamatsu 2022, the glasgow prognostic score and stricture site can predict prognosis after endoscopic duodenal stent placement for malignant gastric outlet obstruction endoscopic ds placements were performed under conscious sedation induced by an intravenous injection of midazolam and/or pentazocine.A lateral-viewing duodenal endoscope (tjf-260v, olympus medical systems, tokyo, japan) or a forward-viewing gastrointestinal endoscope (cf-h260ai, olympus medical systems, tokyo, japan) was used according to the site of the stricture.First, an endoscope was inserted at the proximal site of stenosis with a catheter, and a guidewire passed through the stricture.After confirming the site and length of duodenal stenosis with a contrast medium, the ds was deployed across the stricture under endoscopic and fluoroscopic guidance.According to the site and length of a stricture, a wallflex ds (6, 9, or 12cm in length, 22mm in body diameter; boston scientific, marlborough, ma, united states), niti-s ds (uncovered type 6, 8, 10, or 12cm in length, covered type 8 or 10cm in length, 22mm in body diameter; taewoong medical, seoul, korea) or evolution ds (6, 9, or 12cm in length, 22mm in body diameter; cook medical, winston-salem, nc, united states) was selected based on the endoscopist¿s preference.Evolution, which were all uncovered type, were used in 25 patients.This file will capture 4 patients that were recorded as having cholangitis and 1 patient that had aspiration pneumoniae as a procedure related complication.Require intervention/additional procedures s=4.80 male and 55 female patients.Average age 72 years.

Manufacturer Narrative

Pma/510(k) # k163468.File to be cancelled following review of supplemental table available through the doi link, the evo device didn¿t contribute to any procedure related complications.

• Brand Name: EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED
• Type of Device: MUM STENT, METALIC EXPANDABLE, DUODENAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 16194005
• MDR Text Key: 307569671
• Report Number: 3001845648-2023-00040
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/26/2023

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?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/13/2022
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/21/2022
• Initial Date FDA Received: 01/18/2023
• Supplement Dates Manufacturer Received: 12/21/2022
• Supplement Dates FDA Received: 02/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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