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 Perforation (2001)

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 perforation after sems placement requiring starvation cure.

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.Complaint files (b)(4) (3001845648-2021-00078), (b)(4) (3001845648-2021-00079), (b)(4) (3001845648-2021-00080) and (b)(4) (3001845648-2021-00081) were opened as a result of this paper.This file (b)(4) (3001845648-2021-00080) 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.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: intestinal perforation¿.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 instructions for use, intestinal perforation 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.(ref.Att.Kuroki clinical input) 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
• Manufacturer (Section G): COOK IRELAND; o'halloran road; national technology park; limerick
• Manufacturer Contact: aisling hassett ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 11306822
• MDR Text Key: 234920880
• Report Number: 3001845648-2021-00080
• 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: 02/10/2021
• 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