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 Obstruction/Occlusion (2422); No Information (3190); Insufficient Information (4580)

Event Date 08/07/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Ratone et al 2020 outcomes of duodenal stenting: experience in a french tertiary center with 220 cases a retrospective single-center study was performed using data collected from all patients who received palliative duodenal semss between january 2011 and december 2016.A 0.035-inch guidewire ((b)(4)) was used to traverse the stricture under fluoroscopic guidance, and the stent was then positioned across the stricture and deployed.The length and number of semss were selected by the endoscopist during the procedure.All stents were uncovered.The following uncovered semss were used during the five years of the study: cook evolutiontm (b)(4) 9 and 12.187 cook evolutiontm devices used.The duodenal reintervention rates during the first three months were 28% (23/81) 41 cases of re-intervention after duodenal stent placement up to 30 months.

Event Description

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

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 attached journal article.Reference "ratone et al 2020".Complaint files pr (b)(4) were opened as a result of this paper.This file pr (b)(4) was opened to investigate reintervention.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.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 the patient¿s pre-existing condition.From the information provided it is known that the patient had symptomatic malignant gastroduodenal outlet obstruction.As per medical advisor "reintervention was likely due to patient¿s underlying pathology" summary: complaint is confirmed based on the customers testimony.Complaints of this nature will continue to be monitored for potential emerging trends.

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."ratone et al 2020".Complaint files (b)(4), (b)(4), (b)(4), (b)(4), (b)(4) and (b)(4) were opened as a result of this paper.This file (b)(4) was opened to investigate reintervention.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.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 patient had symptomatic malignant gastroduodenal outlet obstruction.As per medical advisor "reintervention was likely due to patient¿s underlying pathology" summary: complaint is confirmed based on the customers testimony.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental report is being submitted due to an update to annex e code.

• 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: 11313370
• MDR Text Key: 238606515
• Report Number: 3001845648-2021-00088
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup,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?: 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
• Distributor Facility Aware Date: 08/07/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/13/2021
• Initial Date FDA Received: 02/11/2021
• Supplement Dates Manufacturer Received: 01/13/2021; 01/13/2021
• Supplement Dates FDA Received: 06/24/2021; 01/31/2023
• 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: 67 YR
• Patient Sex: Male