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

Model Number G48038

Device Problems Structural Problem (2506); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/29/2021

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #k163468.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

User advanced the delivery system to stenosis, but found out the stent shape deformed during deployment.User retracted the device from patient, then changed to another same device to complete the procedure."a section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence." 1.What is the reorder number of the wire guide used with this device? metii-35-480 metii-35-480.2.If not with the device in question, how was the procedure finished? with another same device to complete the procedure.For complaints occurring during use (once in contact with patient) also ask: 3.What is the endoscope manufacturer and model number that was used during the procedure? olympus cf-hq290i.Cf-hq290i.4.Had dilation of the stricture been performed prior to stent placement? yes.5.What was the diameter of the stricture at the time of stent placement (in mm)? 5mm mm)¿5mm.6.What was the length of the stricture at the time of stent placement (in cm)? 5cm cm)¿5cm.7.Please describe the location in the body where the stent was to be placed.Colon.8.Was resistance encountered when advancing the wire guide through the stricture? yes.9.Was resistance encountered when advancing the introducer and stent into position? yes.10.Did any section of the device detach inside the patient? no.11.After placement, was stent position verified? if yes, please describe how.X-ray.12.After placement, was the endoscope advanced through the stent? no.13.Please estimate amount of time the stent was in place prior to this occurrence.30sec.

Manufacturer Narrative

Pma/510(k) #k163468.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Supplemental report is being submitted due to the completion of a lab evaluation.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 03-feb-2023.

Manufacturer Narrative

Pma/510(k) #k163468.Device evaluation: the device evaluation of evo-25-30-10-c of lot c1791590 was complete on 02 mar 2022.The lock wire was not returned.The red marker was at 4th dimpling on the handle.The stent wire appears to be exposed on return.The handle actuated as intended.The stent deployed without issue but appears to be visually deformed.Confirmation was received that the stent was released and reloaded back into introducer by the customer it is unknown how it was loaded back into introducer.Manufacturing records: prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records of lot number c1791590 did not reveal any discrepancies that could have contributed to this complaint issue.Review historical data: the review of relevant manufacturing records of lot number c1791590 confirms the failure mode has not previously occurred for this work order.Instructions for use and/label: the instructions for use, which accompanies this device, instructs the user to; " if package is opened or damaged when received, do not use.Visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use¿¿ there is no evidence to suggest that the customer did not follow the instructions for use.Root cause analysis: a definitive root cause for the customer complaint could not be determined as circumstances of use cannot be replicated in the laboratory.A possible root cause of the stent deforming could be attributed potentially to a tortuous patient anatomy/ tight stricture.It is known from the available information that resistance was met when advance the stent into position.Summary of investigation: according to the customer the stent shape was deformed on deployment.Confirmed quantity of 1 device, confirmed used.According to the initial report, the patient did not experience any adverse effects due to this occurrence.Investigation findings conclude a possible root cause of the stent deforming could be attributed potentially to a tortuous patient anatomy/ tight stricture.It is known from the available information that resistance was met when advance the stent into position.Complaint confirmed based on customer 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; 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: 13558880
• MDR Text Key: 296387640
• Report Number: 3001845648-2022-00091
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 10827002480381
• UDI-Public: (01)10827002480381(17)230112(10)C1791590
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/03/2023

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 Expiration Date: 01/12/2023
• Device Model Number: G48038
• Device Catalogue Number: EVO-25-30-10-C
• Device Lot Number: C1791590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/29/2021
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/25/2022
• Initial Date FDA Received: 02/18/2022
• Supplement Dates Manufacturer Received: 01/25/2022; 01/25/2022
• Supplement Dates FDA Received: 03/29/2022; 02/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2021
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 67 KG