MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED; MQR STENT, COLONIC METALLIC EXPANDABLE

Catalog Number UNKNOWN

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Obstruction/Occlusion (2422); No Information (3190)

Event Date 02/22/2020

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

Lovero-2020, evo-c, endoscopic stenting for colorectal cancer obstruction as a bridge to surgery strategy in an 8-year period, consecutive patients with acute left-sided colonic obstruction, due to locally advanced colorectal cancer, underwent sems implantation.After the stenting, all patients underwent surgery as an elective procedure.The type of surgery, was left at the surgeon's preference.Of the 22 stents implanted, 2 were evolution colonic stents.Complications in the patients receiving sems were: stent occlusion, perforations, migration, obstruction due to cancer ingrowth, in 1 patient the stent migrated.

Event Description

Supplemental report is being submitted due to the completion of the investigation.

Manufacturer Narrative

510(k) number: k163468.Device evaluation: the colonic devices involved in this complaint were 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 "lovero - 2020".This file was opened to investigate migration.As the rpn and lot number of the complaint devices are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution evo colonic devices are subjected to a visual inspection and functional checks to ensure device integrity.As per the instructions for use, ifu0052-11, which accompanies this device it informs the user about the potential complications "additional complications include, but are not limited to: stent misplacement and/or migration".There is no evidence to suggest that the customer did not follow the instructions for use.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 acute obstructive colorectal cancer.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 correction follow-up report is being submitted due to the review of this complaint on 30-jan-2023.On review imdrf coding was updated as follows: medical device problem code (annex a) : a24 - adverse event without identified device or use problem was updated to a010402 - migration.Type of investigation (annex b) : b11 - historical data analysis and b22 - insufficient.Information available was updated to b13 - communication/interviews and b17 - device not returned.Investigation findings (annex c) : c13 - operational problem identified was updated to c0701 - device migration.Investigation conclusions (annex d): d1001 - adverse event related to patient condition was updated to d12 - known inherent risk of device.

Manufacturer Narrative

Device evaluation: the colonic devices involved in this complaint were 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 "lovero - 2020" this file was opened to investigate migration.Lab evaluation: n/a.Documents review including ifu review: as the rpn and lot number of the complaint devices are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution evo colonic 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 per the instructions for use, ifu0052, which accompanies this device it informs the user about the potential complications "additional complications include, but are not limited to: stent misplacement and/or migration".There is no evidence to suggest that the customer did not follow the instructions for use.Image review: n/a.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 acute obstructive colorectal cancer.A possible root cause could be attributed to patient condition related, as per instructions for use, stent migration is listed as a potential complication following the placement of this device.Summary: complaint is confirmed based on the customers testimony.According to the initial reporter the patient received an additional sems deployment.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED
• Type of Device: MQR STENT, COLONIC METALLIC EXPANDABLE
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND; holstein campus kiel; arnold- keller str- 3; limerick
• Manufacturer Contact: sinead o'leary ; holstein campus kiel; arnold- keller str- 3; limerick
• MDR Report Key: 11342413
• MDR Text Key: 241444700
• Report Number: 3001845648-2021-00127
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/30/2023

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?: Yes
• 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: 02/22/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/22/2021
• Initial Date FDA Received: 02/18/2021
• Supplement Dates Manufacturer Received: 01/22/2021; 01/22/2022
• Supplement Dates FDA Received: 11/30/2021; 02/28/2023
• 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: 71 YR
• Patient Sex: Male