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

Model Number G48038

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/14/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The inner catheter shows to be in the patient 3 days after the stent was implanted.Stent placement required of two recaptures before the final stent placement (no problems); they pulled off the security wire guide (no problem).The stent was perfectly placed and it began to drain all debris, nevertheless they endoscopically saw something weird but couldn't be clearly seen, too much debris.Next monday they made an x-ray and they found what they supposedly saw.A section of the device did remain inside the patient¿s body.The patient did require any additional procedures due to this occurrence.A second colonoscopy to extract the piece of catheter broken and left inside the colon.Note: this file will capture the user error of deployment without fluoroscopy patient outcome: a section of the device did remain inside the patient¿s body.The patient did require any additional procedures due to this occurrence.A second colonoscopy to extract the piece of catheter broken and left inside the colon.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence additional questions; 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) what endoscope type and channel size was used? data in compliant form, attached what was the position of the elevator? was it opened or closed? na.Details of the wire guide used (diameter, type, make)? data in compliant form, attached.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? 4 days.For devices where the ifu states for longer term patency has not been established, was periodic evaluation complete and how often? na.Stricture information: what was the length and diameter of the stricture? not specified, see xray provided.Where was the stricture located in the body? left colon.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? was the directional button pressed during use? yes, 2 times.Was any part of the stent observed in contact with the patient¿s anatomy at the time of failure? yes.Was the yellow marker kept in view during deployment? yes.Are images of the device or procedure available? no.Questions related to during introducer withdrawal was final stent placement confirmed using endoscopy / fluoroscopy? if yes, what was used? yes, but after 3 days.Did the stent open sufficiently to allow withdrawal of introducer safely? yes.Was the safety wire fully removed before removing the delivery system? yes.Did any part of the product snag/get caught with the stent when removing the delivery system? no.Are images of the device or procedure available? no.Questions related to during stent repositioning/removal: what instrument was used for stent repositioning / removal? forceps, snare¿ na was the lasso (suture) loop used during repositioning.

Manufacturer Narrative

Device evaluation: the evo-25-30-10-c device of lot number c1779448 involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.Document 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 of lot number c1779448 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 c1779448.It should be noted that the instructions for use, ifu0052-11, states the following: ¿stent should be placed endoscopically with fluoroscopic monitoring¿.There is sufficient evidence to suggest the user did not follow the ifu.Image review: images were provided to support the complaint investigation.They were reviewed through cook research inc.(cri) and the following impression was provided by the independent reviewer ¿delivery system separation with retention of an inner cannula fragment is confirmed.¿ it was also noted in the findings that ¿the complaint concerns a retained piece of the delivery system after deployment without fluoroscopy¿.Root cause review: a definitive root cause could be determined from the available information.A definitive root cause could be attributed to the user error, as per images review ¿the complaint concerns a retained piece of the delivery system after deployment without fluoroscopy.¿ this would be considered user error.Summary: complaint is confirmed as the failure was verified in the images.It was noted in the findings that ¿the complaint concerns a retained piece of the delivery system after deployment without fluoroscopy¿.A second colonoscopy to extract the piece of catheter broken and left inside the colon was required 3 days after the initial stent was implanted.According to the initial reporter, 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.This file is related to pr (b)(4) (mdr ref:3001845648-2021-00495).

Event Description

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

• 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: aisling hassett ; o halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 12719794
• MDR Text Key: 279036821
• Report Number: 3001845648-2021-00770
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 10827002480381
• UDI-Public: (01)10827002480381(17)221120(10)C1779448
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2022
• Device Model Number: G48038
• Device Catalogue Number: EVO-25-30-10-C
• Device Lot Number: C1779448
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/14/2021
• Event Location: Hospital
• Date Manufacturer Received: 10/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2020
• 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