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 Problem Pneumonia (2011)

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 infectious pneumonia in one patient.The patient with infectious pneumonia was successfully treated with antibiotic therapy.

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.Complaint files (b)(4) were opened as a result of this paper.This file (b)(4) was opened to investigate infectious pneumonia.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.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 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: 11312457
• MDR Text Key: 238873106
• Report Number: 3001845648-2021-00083
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/14/2021

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
• 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
• Supplement Dates FDA Received: 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR