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 Problems Aspiration/Inhalation (1725); Pneumonia (2011)

Event Type  Injury  

Manufacturer Narrative

510(k) number: k163468.Investigation is still in progress, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Jang et al 2019 ¿superiority of gastrojejunostomy over endoscopic stenting for palliation of malignant gastric outlet obstruction.A retrospective cohort study was conducted from the registries of patients who received endoscopic duodenal sems placement andwho underwent gj for the palliation of malignant goo at the (b)(6) clinic between 2011 and 2017.For endoscopic stenting, uncovered, duodenal sems, either wallflex duodenal stent (boston scientific, (b)(4)) or evolution duodenal stent (cook medical, (b)(4)), was placed under endoscopic and fluoroscopic guidance.183 patients with enteral stenting and 127 with gj were included in the study.The complications of endoscopic stenting included aspiration (5 cases).

Manufacturer Narrative

510(k) number: k163468.Device evaluation: the duodenal devices involved in this complaint was not returned to cirl for evaluation.With the information provided, a document based investigation will be complete.This file was created from the journal article " jang et al 2019 " complaint files (b)(4) (mdr ref#3001845648-2021-00091), (b)(4) (mdr ref #3001845648-2021-00092), (b)(4) (mdr ref #3001845648-2021-00093) and (b)(4) (mdr ref #3001845648-2021-00094) were opened as a result of this paper.This file (b)(4) was opened to investigate aspiration.Lab evaluation: n/a documents review including ifu review: as the rpn and lot number of the complaint stents are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution evo duodenal devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.As the evo duodenal devices from unknown lot number, a review of the relevant manufacturing records cannot be conducted.As per the instructions for use, ifu0053-10, which accompanies this device it informs the user about the potential complications ¿those associated with gi endoscopy include, but are not limited to: aspiration¿.There is no evidence to suggest that the customer did not follow the instructions for use.Image review: n/a root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to patient condition related, as per instructions for use, aspiration is listed as a complication following the use of this device.Summary: complaint is confirmed based on the customers testimony.As per medical advisor opinion require intervention/additional procedures s=4.Procedure related complication.It is covered in ifu by aspiration.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental report is being submitted due to the completion of the investigation.

• 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: aisling hassett ; o halloran road; national technology park; limerick
• MDR Report Key: 11314030
• MDR Text Key: 239182388
• Report Number: 3001845648-2021-00091
• 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: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/04/2022

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
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/13/2021
• Initial Date FDA Received: 02/11/2021
• Supplement Dates Manufacturer Received: 01/13/2021
• Supplement Dates FDA Received: 03/30/2022
• 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: 67 YR
• Patient Sex: Female