MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED; MUM STENT, METALIC EXPANDABLE, DUODENAL

Model Number G48025

Device Problems Retraction Problem (1536); Premature Separation (4045)

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

Event Date 06/03/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The stent opened and wouldn't close back even though the release system had not reached the "non return" mark "as per cc form": during stent release, when the stent was partially opened but small adjustments in the endoscope position were made to obtain a better endoscopic view, although the "point-of-no-return" had not been reached neither in the shooting "gun" nor radiologically, the stent released completely.Attempt to reclose the stent were futile, resulting in stent folding.The stent was therefore removed.Additional info received 18-jun-21: "it was removed partially deployed"." a section of the device did not remain inside the patient¿s body.The patient did require any additional procedures due to this occurrence.A new stent was placed according to the initial reporter, the patient did not experience any adverse effects due to this occurrence questions in addition: - was the stent removed from the patient partially deployed? or is the device placed in an unintended location in the patient? it was removed partially deployed - were any kinks/breaks noted on the delivery system after this incident occurred? no.At what stage of the procedure did the complaint occur? during stent release (the distal flange was already opened).What endoscope type and channel size was used? pentax eg-4070k; channel size 3.8 mm.What was the position of the elevator? was it opened or closed? not applicable.Details of the wire guide used (diameter, type, make)? dreamwire straight tip (boston scientific): length 260 cm, distal tip 0.035 in.Did any part of the stent contact the patient¿s anatomy when the complaint occurred? the distal flange of the stent was already released in the duodenum, below the stenosis how long was the stent in the patient by the time this complaint occurred? 5 minutes.For devices where the ifu states for longer term patency has not been established, was periodic evaluation complete and how often? not applicable.Stricture information: what was the length and diameter of the stricture? length: 2 cm and diameter 4 mm.Where was the stricture located in the body? the second part of the duodenum.Was there resistance felt passing wire guide through stricture? no.Was there resistance felt passing the evolution through stricture? no.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? during deployment.Was the directional button pressed during use? the directional button was in the ¿release¿ position when the event happened.Only after the misdeployment, attempt to recapture the stent were made, but failed was any part of the stent observed in contact with the patient¿s anatomy at the time of failure? the stent was half-released, with the distal flange opened below the stenosis in the duodenum.Was the yellow marker kept in view during deployment? yes.Are images of the device or procedure available? we attach one image of the stent and releasing ¿gun¿ after removal.Questions related to during introducer withdrawal was final stent placement confirmed using endoscopy / fluoroscopy? if yes, what was used? yes.Endoscopy and c-arm x-ray machines were used.Did the stent open sufficiently to allow withdrawal of introducer safely? the stent was not released since the final position was not correct.Was the safety wire fully removed before removing the delivery system? since the stent was not in the correct position, the safety wire was not removed, and used to remove the stent.Did any part of the product snag/get caught with the stent when removing the delivery system? the stent was not released are images of the device or procedure available.We attach one image of the stent and releasing ¿gun¿ after removal.Questions related to during stent repositioning/removal what instrument was used for stent repositioning / removal? the stent was removed by pulling back since it was still attached by the safety wire.

Manufacturer Narrative

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 device evaluation 'stent returned fully deployed and detached from the delivery system'.

Event Description

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

Manufacturer Narrative

Pma/510(k) # k163468.Device evaluation: 1 unit of evo-22-27-6-d lot# c1800963 involved in this complaint was returned for evaluation, without the original packaging.The packaging was open on receipt.With the information provided, a physical examination and document-based investigation was conducted.Lab evaluation: the device related to this occurrence underwent a laboratory evaluation on the 22 jul 2021.On evaluation of the device it was noted the stent was retuned fully deployed and detached from the delivery system.The safety wire was not returned.The handle was actuating as intended for both deployment and recapture.Following the lab evaluation additional information was requested and provided to aid this investigation : "following the physical examination of the returned device, can you please ask when and how was the lock wire removed from the delivery system?" - "the lock wire was not removed during the procedure.Indeed it was used to remove the released stent outside the patient.If you find it removed, it was probably done on the table after the procedure." on further review of the image provided the lock wire appears to be attached to the folded stent post procedure.Documents review including ifu review: prior to distribution evo-22-27-6-d 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-22-27-6-d of lot number c1800963 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 c1800963.It should be noted that the instructions for use (b)(4) states the following: ¿additional complications include but are not limited to: stent misplacement." "if stent repositioning is required during deployment, it is possible to recapture stent.Note: it is not possible to recapture stent after passing the point of no return"" when stent point of no return has been passed, pull safety wire out of delivery handle near wire guide port".There is not sufficient evidence to suggest the user did not follow the ifu.Image review: n/a.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 premature deployment due to a combination of user device handling and patient anatomy.It is possible that the partially deployed stent was ¿wedged¿ onto the stenosis and that the endoscope adjustments created a contrasting push/pull effect on the gripped section of the stent which caused the premature deployment.Summary: complaint is confirmed based on the customers testimony as the clinical setting that could impact on the functionality of the device cannot be replicated in the laboratory.According to the initial reporter, the patient required an additional procedure where a new stent was placed.The patient did not experience any adverse effects due to this occurrence complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED
• Type of Device: MUM STENT, METALIC EXPANDABLE, DUODENAL
• 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: aisling hassett ; o halloran road; national technology park; limerick
• MDR Report Key: 12116387
• MDR Text Key: 281671350
• Report Number: 3001845648-2021-00530
• Device Sequence Number: 1
• Product Code: MUM
• UDI-Device Identifier: 10827002480251
• UDI-Public: (01)10827002480251(17)230212(10)C1800963
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 02/10/2022

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 Expiration Date: 02/12/2023
• Device Model Number: G48025
• Device Catalogue Number: EVO-22-27-6-D
• Device Lot Number: C1800963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/03/2021
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/08/2021
• Initial Date FDA Received: 07/05/2021
• Supplement Dates Manufacturer Received: 06/08/2021; 06/08/2021
• Supplement Dates FDA Received: 08/19/2021; 03/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2021
• 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: 69 YR
• Patient Sex: Female
• Patient Weight: 50 KG