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 Hemorrhage/Bleeding (1888); Gastrointestinal Hemorrhage (4476)

Event Date 10/01/2020

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

Ge et al 2020 (evo-d) ¿ ¿eus-guided gastroenterostomy versus enteral stent placement for palliation of malignant gastric outlet obstruction¿.The procedure was performed using a therapeutic gastroscope (gif-xtq160; olympus america, center valley, pa).Once the area of stenosis was reached endoscopically, a standard cannula (tandem xl; boston scientific, marlborough, ma) with 0.035 inch guidewire was advanced across the obstruction.Contrast was injected to delineate the length of the stenosis.An appropriately sized uncovered metal duodenal stent (wallflex duodenal; boston scientific, or evolution; cook medical, bloomington, in) was then deployed under direct endoscopic and fluoroscopic guidance across the stenosis." stent-related bleeding (1.0% of 97).

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 " ge et al 2019 " complaint files (b)(4) (3001845648-2021-00067), (b)(4) (3001845648-2021-00068), (b)(4) (3001845648-2021-00070), (b)(4) (3001845648-2021-00071), (b)(4) (3001845648-2021-00069), (b)(4) (3001845648-2021-00066) and (b)(4) (3001845648-2021-00072) were opened as a result of this paper.This file (b)(4) was opened to investigate stent-related bleeding.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.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: perforation, haemorrhage".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 to patient condition related, as per instructions for use, haemorrhage 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 patient required intervention/additional procedures.(ref.Att.Ge clinical input) 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: 11300038
• MDR Text Key: 231340741
• Report Number: 3001845648-2021-00069
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/11/2022

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
• Distributor Facility Aware Date: 10/01/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/11/2021
• Initial Date FDA Received: 02/09/2021
• Supplement Dates Manufacturer Received: 01/11/2021
• Supplement Dates FDA Received: 03/10/2022
• 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: 66 YR
• Patient Sex: Male