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

Catalog Number UNKNOWN

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Obstruction/Occlusion (2422)

Event Date 01/24/2023

Event Type  Injury  

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 (b)(6) 2010 and (b)(6) 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, (b)(6), 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.Stent dysfunction was defined as the recurrence of mgoo symptoms due to tumor ingrowth and overgrowth, stent migration, and food impaction, as confirmed by radiological and/or endoscopic findings.Stent dysfunction occurred in 37 patients, with a median time to occurrence of 109 (95% ci: 74¿139) days.Complications occurred in 53 cases (24.5%).Stent migration - four cases were complicated by stent migration in this study.Post-stent chemotherapy was defined as systemic chemotherapy application after gds placement as the first-line as well as the second- or third-line treatments.In all, 38 patients underwent chemotherapy after gds, with a median start time to chemotherapy of 14.5 (1¿70) days and a median duration of chemotherapy administration of 133 (6¿638) days.It can be noted that chemotherapy after stent placement is user error.As per ifu0053-11"after stent placement, alternative methods of treatment such as chemotherapy and radiation should not be administered as this may increase risk of stent migration due to tumor shrinkage, stent erosion or and or/ mucosal bleeding." 3 evolution stents were placed in this study.This complaint will capture the potential that there was evo stent migration and post-stent chemotherapy.Patient outcome: no information provided in study.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 (b)(6) 2010 and (b)(6) 2020.Male (51%) median patient age was 76 (68¿86) years.

Manufacturer Narrative

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

• 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: 18265215
• MDR Text Key: 329673234
• Report Number: 3001845648-2023-00883
• 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

• 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
• Initial Date Manufacturer Received: 11/06/2023
• Initial Date FDA Received: 12/05/2023
• 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