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

Catalog Number UNKNOWN

Device Problems Off-Label Use (1494); Activation Failure (3270)

Patient Problems Obstruction/Occlusion (2422); No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/05/2020

Event Type  malfunction  

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

Zhou-2020 (evo-c): safety and efficacy of through-the-scope placement of colonic self-expandable metal stents without fluoroscopic guidance: a retrospective cohort study.Retrospective study carried out in patients undergoing endoscopic sems insertion with or without fluoroscopic guidance for malignant large-bowel obstruction in a single tertiary medical center.Sems placement was performed using a 1-channel endoscope with working channel = 3.7 mm diameter (cf-h260; olympus co., tokyo, japan).The stenting procedures are briefly summarized as follows: in the f group, a hydrophilic guidewire and a biliary dilation catheter (cook medical, winston-salem, nc) were inserted through the stricture.Then, the guidewire was removed and a water-soluble contrast agent was injected through catheter to insure proper entry into the proximal lumen and to evaluate the length of the stenosis under fluoroscopy.Then, after the guidewire was reinserted and the dilation catheter was withdrawn, the stent was advanced through the endoscope across the lesion and deployed under endoscopic and fluoroscopic guidance.In the nf group, procedures were otherwise the same as in f group, except that fluoroscopy was not used and contrast agent injection was omitted (off-label use).Guidewire and dilation catheter were considered across the stricture when they were easily advanced without resistance.When resistance was felt, the guidewire tip direction was adjusted.Insertion was retried until easy advance of at least 10 cm of both the guidewire and the catheter.The stent was deployed only under endoscopic monitoring.Stent length must allow for at least 2 cm of additional exposure to each end of the stricture.If one stent was not long enough to cover the obstruction, a second stent was used and at least 3 cm of overlap was obtained.In 2 patients, stents were placed without fluoroscopic guidance (off-label) and clinical success was not achieved as there was poor stent expansion.

Event Description

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

Manufacturer Narrative

510(k) number: k163468.Note: 'complaint investigation due on' date and 'complaint closure due on' date updated.Device evaluation: the evolution colonic devices of unknown lot number involved in this complaint were not available for evaluation.With the information provided, a document based investigation was conducted.This file was created from the attached journal article to capture ¿zhou-2020 (evo-c): safety and efficacy of through-the-scope placement of colonic self-expandable metal stents without fluoroscopic guidance: a retrospective cohort study.Additional complaint files pr320496 ,pr320500, pr320502 , pr320505, pr320506 , pr320508 , pr320509 , pr320511 , pr320512 and pr320513 were opened as a result of this paper.Reference "zhou-2020.Pdf".Lab evaluation: n/a.Document review including ifu review: as the evolution colonic devices are from unknown lot number, a review of the relevant manufacturing records cannot be conducted.Prior to distribution, all evolution colonic devices are subjected to functional checks and visual inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.The notes section of the instructions for use, ifu0052-11, which accompanies this device instructs the user "stent should be placed endoscopically with fluoroscopic monitoring.It is likely the poor stent expansion could be linked to placement of stent without fluoroscopic monitoring.There is 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 be determined from the available information.From the journal article it is known that the user used the device off-label, stents were placed without fluoroscopic guidance which is off label as per ifu.Summary: complaint is confirmed based on the customer's testimony.No patient death was reported.Complaints of this nature will continue to be monitored for potential emerging trends.

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)." this file (b)(4) (3001845648-2021-00125) was opened to investigate poor stent expansion in the non-fluoroscopic group.User error user error event for not using fluoroscopic guidance/monitoring is captured under pr (b)(4) (3001845648-2021-00132).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 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 contraindications include, but are not limited to : "inadequate stent expansion.¿ 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, inadequate stent expansion is listed as a possible complication.Also it is known all patients had pre-existing condition of malignant colorectal obstruction.Summary: complaint is confirmed based on the customers testimony.According to the initial reporter, the patient outcome is unknown.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental report is being submitted due to a correction on the file.A code updated to a2303 and g code to g07001.

• 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: 11342065
• MDR Text Key: 280451002
• Report Number: 3001845648-2021-00125
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/02/2022

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/05/2020
• 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 Age: 71 YR
• Patient Sex: Male