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

Patient Problems Abdominal Pain (1685); Discomfort (2330); Abdominal Cramps (2543)

Event Date 01/10/2020

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

As per paper - "after stent insertion, two patients suffered from tenesmus.Feng et al 2020 ¿ endoscopic self-expandable metallic stent insertion without fluoroscopic guidance is feasible and safe for acute colonic obstruction caused by colorectal cancer the objective of this study was to evaluate the efficacy and feasibility of this technique using sems insertion.From january 2016 to december 2018, 36 patients with crc obstruction underwent endoscopic sems insertion in our center.The whole stenting procedure was monitored under endoscopic guidance only.A through-the-scope technique was used for all stent insertions.A niti-s uncovered colorectal stent with a diameter of 22¿25mm and a length of 100mm from microtech (nanjing, china) or cook medical evolution(bloomington,in,usa) was used according to the endoscopist¿s preference.Briefly, when the colonoscope reached the obstruction, a sphincterotome (microtech, nanjing, china) for endoscopic retrograde cholangiopancreatography (ercp) with a 0.035-inch guidewire (micro-tech, nanjing, china) or jagwire (boston scientific, natick, ma, usa) was introduced.The guidewire was inserted to traverse the stricture.The guidewire was inserted for approximately 40 cm, then pulled backward at approximately 10 cm, followed by an additional insertion for approximately 20 cm.Successful guidewire insertion was judged by a smooth passage of the guidewire without any resistance.The sphincterotome was then inserted along the guidewire to confirm the passage of the obstruction.The delivery system was advanced over the guidewire and was guided into the site of obstruction until the distal end of the stent was approximately 2cm at the edge of the tumor.In the stent deployment procedure, the distal end of the stent was kept 2cm beyond the distal edge of the lesion, while the outer sheath was retracted.The whole procedure was monitored by the colonoscopic guidance only.After stent insertion, two patients suffered from tenesmus.The patients obtained symptom relief after conservative therapy.The exact rpn unknown, 3 possible rpns: evo-25-30-6-c, evo-25-30-8-c ,evo-25-30-10-c.It cannot be confirmed of the overall 36 stents placed, which were cook stents, this file is created to capture the potential that it could have been a cook evolution stent.This file was created to capture two cases of tenesmus.

Manufacturer Narrative

510(k) number: k163468.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 " feng et al 2020 " complaint files pr306254, pr 306256 and pr 306266 were opened as a result of this paper.This file pr306266 was opened to investigate tenesmus.Lab evaluation: n/a.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 from unknown lot number, a review of the relevant manufacturing records cannot be conducted.There is no evidence to suggest that the customer did not follow the instructions for use.Image review: n/a.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 patients had acute colonic obstruction.Complaint is confirmed based on the customers testimony.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

This supplemental report is being submitted due to the completion of the investigation.

Event Description

This supplemental report is being submitted due to correct the imdrf a code from previously submitted mdr report.

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 journal article.Reference " feng et al 2020 " this file was opened to investigate tenesmus 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 from unknown lot number, a review of the relevant manufacturing records cannot be conducted.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 patients had acute colonic obstruction.Summary: complaint is confirmed based on the customers testimony.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; national technology park; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: aisling hassett ; o halloran road; national technology park; limerick
• MDR Report Key: 10433613
• MDR Text Key: 206822677
• Report Number: 3001845648-2020-00515
• 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: 02/23/2022

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?: 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?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/10/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/23/2020
• Initial Date FDA Received: 08/20/2020
• Supplement Dates Manufacturer Received: 07/23/2020; 07/23/2020
• Supplement Dates FDA Received: 07/08/2021; 03/23/2022
• 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: 73 YR
• Patient Sex: Male