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

Catalog Number UNKNOWN

Device Problem Complete Blockage (1094)

Patient Problem Obstruction/Occlusion (2422)

Event Date 05/26/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Harima et al 2022 - comparison of duodenal stenting and gastrojejunostomy for duodenal obstruction with biliary obstruction.The present study aimed to compare clinical outcomes between dus and gj in patients with double obstruction who underwent biliary stenting.The present study further aimed to analyze the risk factors associated with survival time and time to recurrent biliary obstruction (trbo) dus was performed using evolution duodenal stent; 22-mm diameter,was performed either with an open or laparoscopic approach based on the description of performing surgeons.Biliary stenting was performed with the ptbd approach, ercp approach or eus-bd approach based on the description of the performing physicians.For the ptbd approach, an uncovered 10-mm-diameter sems (epic biliary stent; boston scientific) was placed after temporary external drainage.For the ercp approach, a covered or an uncovered 10-mm-diameter sems was placed, and when eus-guided hepaticogastrostomy combined with antegrade stenting (eus-hgas) was performed, an uncovered 10-mm-diameter sems (zilver stent; cook medical or niti- s large cell sr slim delivery; taewoong medical) and a dedicated 8-fr plastic stent were placed.This complaint was opened to capture biliary obstruction.84 underwent dus.Age 72.Male, n 39(46.4%).

Manufacturer Narrative

Pma/510(k) # (b)(4).Cancellation mdr report is being submitted based on additional clinical input confirming the evolution® duodenal controlled-release stent - uncovered was not involved in the bliary obstruction reported in this literature paper.Additional clinical input received on 18-aug-2023 as follows: "for a conservative assessment, there would be a possibility that zilver stent was involved in this biliary obstruction however the chance is very low.Zilver stent was used off-label with the eus-bd approach in this article." based on this clinical review the biliary obstruction was not caused the evo-d device as initially reported.This complaint is now being cancelled.(b)(4) / mdr ref# 3001845648-2023-00038 captures the biliary obstruction potentially caused by the zilver device.

Event Description

Cancellation mdr report is being submitted based on additional clinical input confirming the evolution duodenal controlled-release stent - uncovered was not involved in the biliary obstruction reported in this literature paper.Additional clinical input received on 18-aug-2023 as follows: "for a conservative assessment, there would be a possibility that zilver stent was involved in this biliary obstruction however the chance is very low.Zilver stent was used off-label with the eus-bd approach in this article." based on this clinical review the biliary obstruction was not caused the evo-d device as initially reported.This complaint is now being cancelled.(b)(4) / mdr ref# 3001845648-2023-00038 captures the biliary obstruction potentially caused by the zilver device.

• 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: 16205850
• MDR Text Key: 307701412
• Report Number: 3001845648-2023-00037
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/18/2023

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?: Yes
• 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?: No
• Distributor Facility Aware Date: 05/26/2022
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/21/2022
• Initial Date FDA Received: 01/19/2023
• Supplement Dates Manufacturer Received: 12/21/2022
• Supplement Dates FDA Received: 09/12/2023
• 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
• Patient Age: 72 YR
• Patient Sex: Female