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 Perforation (2001)

Event Date 01/24/2023

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

Hodo et al 2023- prognostic impact of clinical outcome after endoscopic gastroduodenal stent placement for malignant gastric outlet obstruction: a multicenter retrospective cohort study using a time-dependent analysis.For this study, 219 consecutive patients diagnosed with mgoo due to unresectable cancer and who underwent endoscopic gds placement at the (b)(6) hospital or its 14 affiliated hospitals were enrolled between april 2010 and august 2020.Male (51%) median patient age was 76 (68¿86) years.The stricture was identified endoscopically, and the guidewire was passed through the stenosis.After confirming the location and length of duodenal stenosis using a contrast medium, the duodenal stent was positioned across the stricture under endoscopic and fluoroscopic guidance.Stent type and length were chosen according to stricture site and length.A wallflex ds (6, 9, or 12 cm in length, 22 mm in body diameter; boston scientific, marlborough, ma, usa), niti-s ds (covered or uncovered types 6, 8, 10, or 12 cm in length, 22 mm in body diameter; taewoong medical, seoul, korea), or evolution ds (6, 9, or 12 cm in length, 22 mm in body diameter; cook medical, winston-salem, nc, usa) was selected based on the physician¿s judgment.Finally, the stent was deployed, and its patency was confirmed by injecting a contrast medium.Regarding gds types, niti-s was used in 174 cases, wall flex in 39 cases, and evolution in 3 cases.The stent was placed on the oral side of the papilla in 133 cases, across the papilla in 53 cases, and on the anorectal side of the papilla in 30 cases.Post-stent cholangitis was defined by the presence of biliary dilatation confirmed via imaging examination coupled with clinical symptoms and biochemical evidence of cholestasis.Post-stent cholangitis occurred in 42 patients, with a median time to occurrence of 12.5 days.Perforation was noted in 2 patients (as per supplemental table 3) it can be noted that 3 evolution stents were used in this study.This complaint will capture the potential that the evo stents could have caused the cholangitis or perforation.Drainage for cholangitis was performed in 19 cases, including self-expandable metallic stent placement in 8 cases, plastic stent placement in 5 cases, percutaneous transhepatic cholangio drainage in 4 cases, endoscopic ultrasound-guided biliary drainage in 1 case, and endoscopic nasobiliary drainage in 1 case.No information was provided in this study in relation to any treatment the patients received as a result of perforation.

• 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: 18266597
• MDR Text Key: 329727243
• Report Number: 3001845648-2023-00890
• 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: Other
• Type of Report: Initial
• Report Date: 11/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• 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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/24/2023
• Event Location: Hospital
• Date Manufacturer Received: 11/06/2023
• 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: 76 YR
• Patient Sex: Male