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

Catalog Number UNKNOWN

Device Problems Partial Blockage (1065); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Obstruction/Occlusion (2422)

Event Date 10/01/2020

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

Ge et al 2020 (evo-d)  eus-guided gastroenterostomy versus enteral stent placement for palliation of malignant gastric outlet obstruction the procedure was performed using a therapeutic gastroscope (gif-xtq160; olympus america, (b)(4)).Once the area of stenosis was reached endoscopically, a standard cannula (tandem xl; boston scientific, (b)(4)) with 0.035 inch guidewire was advanced across the obstruction.Contrast was injected to delineate the length of the stenosis.An appropriately sized uncovered metal duodenal stent (wallflex duodenal; boston scientific, or evolution; cook medical, (b)(4)) was then deployed under direct endoscopic and fluoroscopic guidance across the stenosis." stent-related biliary obstruction (2.1% of 97).

Manufacturer Narrative

Pma/510(k) #: 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 " ge et al 2019 " complaint files (b)(4) (3001845648-2021-00067),(b)(4)(3001845648-2021-00068), (b)(4) (3001845648-2021-00070), (b)(4) (3001845648-2021-00071), (b)(4) (3001845648-2021-00069), (b)(4) and (b)(4) (3001845648-2021-00072) were opened as a result of this paper.This file(b)(4) was opened to investigate stent-related biliary obstruction.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 which accompanies this device it informs the user about the potential complications "additional complications include, but are not limited to : stent occlusion".There is no evidence to suggest that the customer did not follow the instructions for use.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, stent occlusion 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 patients required intervention/additional procedures.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: 11299864
• MDR Text Key: 240137191
• Report Number: 3001845648-2021-00066
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 02/11/2022

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?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/01/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/11/2021
• Initial Date FDA Received: 02/09/2021
• Supplement Dates Manufacturer Received: 01/11/2021
• Supplement Dates FDA Received: 03/10/2022
• 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: 66 YR
• Patient Sex: Male