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 10/22/2019

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

Ahmed, 2019, evo-c, colonic stent placement for malignant obstruction: a single centre (b)(6) experience.A 5 year retrospective review of patients in whom colonic stenting for malignant obstruction was attempted ((b)(6) 2014 - (b)(6) 2019).47% (17/36) of patients were stented with a view to subsequent surgery.53% (19/36) were stented for palliative treatment only.Stents were placed in the sigmoid colon in 44% (16/36), descending colon in 17% (6/36) and splenic flexure in 17% (6/36).Uncovered cook evolution stents were used in all cases, from 6-10cm in length.1 partial stent obstruction, managed conservatively.

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 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 (b)(4).Complaint files (b)(4) were opened as a result of this paper.This file (b)(4) was opened to investigate partial stent 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 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 colonic devices arise from unknown lot number, a review of the relevant manufacturing records cannot be conducted.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 : 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 a malignant obstruction.Summary: complaint is confirmed based on the customers testimony.According to the initial reporter, managed conservatively.No patient died of adverse events.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 investigation including imdrf coding.

Manufacturer Narrative

510(k) number: k163468.Device evaluation: the evo 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."ahmed- 2019" complaint files (b)(4) (3001845648-2021-00130) and (b)(4)(3001845648-2021-00131) were opened as a result of this paper.This file (b)(4) (3001845648-2021-00131) was opened to investigate partial stent 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 arise from 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 to patient condition related, 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 'require hospitalisation/prolong hospitalisation' 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: 11347291
• MDR Text Key: 242886662
• Report Number: 3001845648-2021-00131
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• 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: 10/22/2019
• 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): Hospitalization; Required Intervention
• Patient Age: 69 YR