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

Catalog Number UNKNOWN

Device Problems Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Occlusion (1984); Obstruction/Occlusion (2422)

Event Date 02/22/2020

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

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 2 patients, occlusive symptoms persisted despite correct positioning of the stent at fluoroscopy.

Manufacturer Narrative

Pma/510(k) #: k163468.Device evaluation: the colonic 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 attached journal article.Reference "lovero-2020 " complaint files (b)(4), (b)(4), (b)(4), and (b)(4) were opened as a result of this paper.This file (b)(4) was opened to investigate occlusion.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 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 the evo colonic devices are from an unknown lot number, a review of the relevant manufacturing records cannot be conducted.As per the instructions for use, ifu (b)(4), which accompanies this device it informs the user about the potential complications "additional complications include, but are not limited to: tumor ingrowth or overgrowth , stent occlusion ¿ 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 locally advanced colorectal cancer.Summary: complaint is confirmed based on the customers testimony.According to the initial reporter, patient successfully underwent follow-up surgery.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.

Manufacturer Narrative

Pma/510(k) #: k163468.Device evaluation: the colonic 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."lovero-2020 ".Complaint files pr (b)(4) (3001845648-2021-00129), pr 320039 (3001845648-2021-00123), pr (b)(4) (3001845648-2021-00127), and pr (b)(4) (3001845648-2021-00135) were opened as a result of this paper.This file (b)(4) (3001845648-2021-00129) was opened to investigate occlusion.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 colonic devices are subjected to a visual inspection and functional checks to ensure device integrity.As the evo colonic devices are from an unknown lot number, a review of the relevant manufacturing records cannot be conducted.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 : tumor ingrowth or overgrowth , stent occlusion ¿ 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 conditions occurring during device use.As per instructions for use, stent occlusion is listed as a complication following the placement of this device.However, as the device was not returned for evaluation; the cause of this complaint could not be conclusively determined.Summary: complaint is confirmed based on the customers testimony.As per medical advisor, patient outcome "require intervention/additional procedures" complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental report is being submitted due to a corrections to the completed investigation and multiple fields including imdrf coding.

• 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 LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 11343007
• MDR Text Key: 241431695
• Report Number: 3001845648-2021-00129
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• 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: 02/22/2020
• Event Location: Hospital
• Date Manufacturer Received: 01/22/2021
• 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: 71 YR
• Patient Sex: Male