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

Model Number G48038

Device Problems Break (1069); Material Deformation (2976)

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

Event Date 01/04/2021

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 device through endoscopy to desire position and pull the trigger while found out the stent cannot be released.User then retracted the delivery system from patient and pulled the trigger to release the stent but failed.User then changed another same device to complete the procedure.Device evaluated on 28-jan-2021: "broken flexor.Directional button stuck"."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." at what stage of the procedure did the complaint occur?(when unpacking or preparing the evolution, while inserting the evolution in the patient, during stent placement, while removing the introducer, or during stent repositioning/removal) during stent placement.What endoscope type and channel size was used? olympus , model unknown.What was the position of the elevator? was it opened or closed? no elevator.Details of the wire guide used (diameter, type, make)? boston scientific 0.0.35 yellow zebra wire guide.Did any part of the stent contact the patient¿s anatomy when the complaint occurred? yes.How long was the stent in the patient by the time this complaint occurred? stent was not released.For devices where the ifu states for longer term patency has not been established, was periodic evaluation complete and how often? unknown.Stricture information: what was the length and diameter of the stricture? around 4-5cm.Where was the stricture located in the body? intestinal tract.Was there resistance felt passing wire guide through stricture? slight resistance.Was there resistance felt passing the evolution through stricture? slight resistance.Was the stricture dilated before stent placement? no.Questions related to during insertion into patient was the product inspected for kinks or damage before use? yes.Was resistance felt during insertion into patient? if yes, at what point? no.Questions related to during stent placement did the product fail during stent deployment or recapture? stent was not released.Was the directional button pressed during use? no.Was any part of the stent observed in contact with the patient¿s anatomy at the time of failure? no.Was the yellow marker kept in view during deployment? stent was not released are images of the device or procedure available? no.

Manufacturer Narrative

Pma/510(k) #: k163468.Device evaluation.The evo-25-30-10-c device of lot number c1729343 involved in this complaint was returned for evaluation,open in its original packaging.With the information provided, a physical examination and document-based investigation was conducted.Lab evaluation including ifu review: the device related to this occurrence underwent a laboratory evaluation on the 28 jan 2021 and a subsequent re-evaluation on 05 feb 2021.On evaluation of the device a broken flexor was observed at 27cm approximately from the tip.It was also observed that the directional button was stuck.The red shuttle deployment marker was observed at the start of the handle.Unable to press the directional button as it appears to be stuck.The handle on the device was opened and one of the cogs was found to be broken.After the lab evaluation engineering input was sought and it was confirmed that both failures were related and that it is likely the broken flexor caused a build up of pressure and the cog to break.Both failures are related as it is possible that the broken flexor occurred first and caused the cog breakage.Document review including ifu review: prior to distribution evo-25-30-10-c 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 a review of the manufacturing records for evo-25-30-10-c devices of lot number c1729343 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records, confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1729343.The instructions for use ifu0052-11 which accompanies this device instructs the user to "visually inspect with particular attention to kinks, bends and breaks.If 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 review a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to the torturous patient anatomy.It is possible that during deployment tortuous path may have caused a build-up of pressure resulting in the flexor break.Customer feedback indicated there was slight resistance felt while advancing the device through the stricture.Additionally it is possible that excessive force was applied during procedure, as there was a kink evident in the flexor which could indicate that some force may have been applied at some stage.Engineering input was sought and it was confirmed that both failures were related and that it is likely the broken flexor caused a build up of pressure and the cog to break.Summary.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaint is confirmed as the failure was verified in the laboratory.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

Ma/510(k) #: k163468.The evo-25-30-10-c device of lot number c1729343 involved in this complaint device was returned for evaluation, open in its original packaging.With the information provided, a physical examination and document based investigation was conducted.The device involved in the complaint was evaluated in the laboratory.In summary the following results were observed in the lab evaluation: a broken flexor was observed at 27cm approximately from the tip.It was also observed that the directional button was stuck.The red shuttle deployment marker was observed at the start of the handle.Unable to press the directional button as it appears to be stuck.The handle on the device was opened and one of the cogs was found to be broken.Both failures are related as it is possible that the broken flexor occurred first and caused the cog breakage.Following the lab evaluation engineering input was sought and it was confirmed that both failures were related and that it is likely the broken flexor caused a build up of pressure and the cog to break.Both failures are related as it is possible that the broken flexor occurred first and caused the cog breakage.Prior to distribution all evo-25-30-10-c 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.A review of the manufacturing records for evo-25-30-10-c device of lot number c1729343 did not reveal any discrepancies that could have contributed to this issue.The instructions for use which accompanies this device instructs the user to "visually inspect with particular attention to kinks, bends and breaks.If 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.A definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to the torturous patient anatomy.It is possible that during deployment tortuous path may have caused a build-up of pressure resulting in the flexor break.Customer feedback indicated there was slight resistance felt advancing the device through the stricture.Engineering input was sought and it was confirmed that both failures were related and that it is likely the broken flexor caused a build up of pressure and the cog to break.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence complaint is confirmed as the failure was verified in the laboratory.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental correction report is being submitted due to a correction to the medical device problem code (annex a) a0406 - material deformation updated to a0401 - break.

• 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: 11266804
• MDR Text Key: 272970271
• Report Number: 3001845648-2021-00041
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 10827002480381
• UDI-Public: (01)10827002480381(17)220429(10)C1729343
• Combination Product (y/n): N
• Reporter Country Code: CN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/11/2021
• Device Model Number: G48038
• Device Catalogue Number: EVO-25-30-10-C
• Device Lot Number: C1729343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/04/2022
• Event Location: Hospital
• Date Manufacturer Received: 01/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2019
• 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
• Patient Weight: 50 KG