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

Catalog Number UNKNOWN

Device Problems Positioning Failure (1158); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Obstruction/Occlusion (2422); No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)

Event Date 10/01/2020

Event Type  Injury  

Manufacturer Narrative

510(k) number: 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." the incidence of stent failure resulting in venting gastrostomy tube placement (5.2% of 97).One patient (1.0%) in the enteral stent group ultimately underwent conversion to eus-ge following stent failure.

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) (report reference number - 3001845648-2021-00071), (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 - 3001845648-2021-00072) was opened to investigate stent failure.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.¿stent failure was defined as recurrent symptoms of goo such as nausea, vomiting, or inability to tolerate oral intake; the need for unplanned endoscopic or surgical re-intervention for goo; or the need for palliative venting gastrostomy tube placement for refractory goo not amenable to further endoscopic or surgical management¿.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 the patient¿s pre-existing condition.From the information provided it is known that the patients had symptomatic gastric outlet obstruction.Summary: complaint is confirmed based on the customers testimony.As per article patients underwent conversion to eus-ge following stent failure.Complaints of this nature will continue to be monitored for potential emerging trends.

Manufacturer Narrative

Pma/510(k) # k163468 supplemental follow-up report is being submitted as a cancellation report due to clinical input received on 05-jan-2023.Clinical input received as follows : as per the definition of stent failure in this article ¿ ¿stent failure was defined as recurrent symptoms of goo such as¿¿, this goo was due to stent failure due to stent failure rather than a pre-existing condition.Any stent dysfunctions leading to repeat intervention would be considered stent failure which in this study refers to stent migration and stent obstruction (not including ingrowth).(b)(4) /mdr ref# 3001845648-2021-00068 has already covered stent obstruction, and (b)(4) /mdr ref# 3001845648-2021-00070 has already covered stent migration.(b)(4) (this complaint) (stent failure) seems redundant and file is being cancelled.

Event Description

Supplemental follow-up report is being submitted as a cancellation report due to clinical input received on 05-jan-2023.Clinical input received as follows : as per the definition of stent failure in this article ¿ ¿stent failure was defined as recurrent symptoms of goo such as¿¿, this goo was due to stent failure due to stent failure rather than a pre-existing condition.Any stent dysfunctions leading to repeat intervention would be considered stent failure which in this study refers to stent migration and stent obstruction (not including ingrowth).(b)(4) /mdr ref# 3001845648-2021-00068 has already covered stent obstruction, and (b)(4) /mdr ref# 3001845648-2021-00070 has already covered stent migration.(b)(4) (this complaint) (stent failure) seems redundant and file is being cancelled.

• 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: 11300468
• MDR Text Key: 234697938
• Report Number: 3001845648-2021-00072
• 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: 01/05/2023

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
• 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: 01/27/2023
• 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: 66 YR
• Patient Sex: Male