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 Aspiration/Inhalation (1725); Pneumonia (2011)

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

Kuroki et al 2018 (evo-d) ¿ ¿efficacy and safety of endoscopic duodenal stenting: a retrospective clinical study¿.Goo was caused by gastric cancer in 11 patients (28%), pancreatic cancer in 22 (56%), cholangiocarcinoma in 2 (5%), gall bladder cancer in 3 (8%), and colon cancer in 1 (3).Twelve stents (31%) were mainly located in stomach, 3 (8%) were in 1st part of duodenum, 12 (31%) were in 2nd part, 11 (28%) were in 3rd part, and 1 (3%) was more distal.The mean length of stenosis was 42 ± 22 mm.We used wallflex stent in 23 patients (59%), niti-s stent in 12 (31%), and evolution stent in 4 (10%).1 aspiration pneumonitis requiring starvation cure.

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 " kuroki et al 2018 ".Complaint files (b)(4) (report reference number - 3001845648-2021-00078), (b)(4) (report reference number - 3001845648-2021-00079), (b)(4) (report reference number - 3001845648-2021-00080) and (b)(4) (report reference number - 3001845648-2021-00081) were opened as a result of this paper.This file (b)(4) (report reference number - 3001845648-2021-00081) was opened to investigate aspiration pneumonitis.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 potential complications ¿those associated with gi endoscopy include, but are not limited to: aspiration¿.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.As per the instructions for use, aspiration is listed as a complication following the use of this device.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: 11302958
• MDR Text Key: 234919153
• Report Number: 3001845648-2021-00081
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/16/2022

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
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/12/2021
• Initial Date FDA Received: 02/09/2021
• 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: 73 YR