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); Improper or Incorrect Procedure or Method (2017)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/05/2020

Event Type  malfunction  

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the length of the stenosis under fluoroscopy.Then, after the guidewire was reinserted and the dilation catheter was withdrawn, the stent was advanced through the endoscope across the lesion and deployed under endoscopic and fluoroscopic guidance.In the nf group, procedures were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 56 patients, stents were placed without fluoroscopic guidance (off-label).

Manufacturer Narrative

510(k) number: k163468 the investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Manufacturer Narrative

510(k) number: k163468 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 (b)(4) were opened as a result of this paper.Reference "zhou-2020.Pdf".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 ¿ there is evidence to suggest that the customer did not follow the instructions for use.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.

Event Description

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

Manufacturer Narrative

Pma/510(k) # k163468.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 (b)(4)were opened as a result of this paper.Reference (b)(4).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 which accompanies this device instructs the user "stent should be placed endoscopically with 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 of user error could be determined from the available information.From the journal article it is known that the user has not complied with the requirements of the ifu and/label.According to the information available the customer placed the stents without the use of fluoroscopic guidance.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.

Event Description

Supplemental follow-up report is being submitted due to correction and updating the file as follows: annex a 'medical device problem code' was updated from code a2304-off-label use to code a2303- improper or incorrect procedure or method and annex g 'component' code was updated from code g04122 (g04122- stent ) to g07001 (g07001- part/component/sub-assembly term not applicable).

• 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: 11345320
• MDR Text Key: 280449564
• Report Number: 3001845648-2021-00132
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/05/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/22/2021
• Initial Date FDA Received: 02/18/2021
• Supplement Dates Manufacturer Received: 01/22/2021; 01/22/2021
• Supplement Dates FDA Received: 07/07/2021; 01/03/2023
• 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 Age: 71 YR
• Patient Sex: Male