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 Perforation (2001); Bowel Perforation (2668)

Event Date 08/07/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Ratone et al 2020 ¿outcomes of duodenal stenting: experience in a (b)(6) tertiary center with 220 cases¿.A retrospective single-center study was performed using data collected from all patients who received palliative duodenal semss between (b)(6) 2011 and (b)(6) 2016.A 0.035-inch guidewire (jag-wire boston scientifictm, (b)(4) usa) 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 (cook (b)(4)) 9 and 12.187 cook evolutiontm devices used.Four patients (2%) presented a complication related to sems placement.These complications included perforation during the procedure in one patient, and secondary perforations in two patients (60 days and 54 days after duodenal sems placement).The 3 patients with immediate or secondary perforations died; no emergency surgery was performed because the patients had end-stage oncological pathologies.As per clinical input received the evo stent did not cause or contribute to the patient¿s death as the patients had end-stage oncological pathologies.

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 (b)(4) were opened as a result of this paper.This file (b)(4) was opened to investigate perforation.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.(d00059776 (qsi0975) rev 031, d00052106 (prd0281) rev 015, d00055312 (fqc0172)rev 015).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 "additional complications include, but are not limited to : perforation, hemorrhage".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 "this perforation was likely due to patient¿s pre-existing condition" summary: complaint is confirmed based on the customers testimony.According to the initial reporter, the patient death was reported.As per medical advisor input "the ¿death¿ was not related to the stent, it was likely due to patient¿s pre-existing condition as author mentioned below in the article which means the death was expected due to a low median overall survival time." 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
• MDR Report Key: 11312466
• MDR Text Key: 238883025
• Report Number: 3001845648-2021-00084
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• 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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/07/2019
• Event Location: Hospital
• Date Manufacturer Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR