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

Catalog Number UNKNOWN

Device Problem Use of Device Problem (1670)

Patient Problems Obstruction/Occlusion (2422); No Information (3190)

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." inadequate stent length requiring repeat intervention (2.1% of 97).

Event Description

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

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) (report reference number - 3001845648-2021-00067), (b)(4) (report reference number - 3001845648-2021-00068), (b)(4) (report reference number - 3001845648-2021-00070), (b)(4), (b)(4) (report reference number - 3001845648-2021-00069), (b)(4) (report reference number - 3001845648-2021-00066) and (b)(4) (report reference number - 3001845648-2021-00072) were opened as a result of this paper.This file (b)(4) (report reference number - 3001845648-2021-00071) was opened to investigate user error-inadequate stent length.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 selection of stent "a stent length of at least 4cm longer than the stricture is recommended (e.G approximately 2cm longer at either end of the stricture".There is evidence to suggest that the customer did not follow the instructions for use.A definitive root cause could be determined from the available information.A definitive root cause could be attributed to the user error, as incorrect stent size length device was chosen to cover the stricture length.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.

• 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: 11300073
• MDR Text Key: 238334222
• Report Number: 3001845648-2021-00071
• 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: 03/03/2022

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: 03/31/2022
• 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