MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT -FULLY COVERED; ESW PROSTHESIS, ESOPHAGEAL

Model Number G51183

Device Problems Activation Failure (3270); Physical Resistance/Sticking (4012)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 05/28/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

As reported to customer relations via phone conversation "the stent would open, but would not deploy.Another g51183-evo-fc-18-23-12-e was opened and used to complete the procedure successfully.".

Manufacturer Narrative

Device evaluation: the evo-fc-18-23-12-e device of lot number c1560725 involved in this complaint device was not returned for evaluation.With the information and images provided document based investigation was conducted.Documents review including ifu review: prior to distribution all evo-fc-18-23-12-e 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-fc-18-23-12-e device of lot number c1560725 did not reveal any discrepancies that could have contributed to this issue.There is no evidence to suggest that this issue affects the entire lot #c1560725 ; upon review of complaints this failure mode has not occurred previously with this lot #c1560725.The instructions for use ifu0061-5 which accompanies this device instructs the user to "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.From additional information received, "sorry for the confusion, it appears that the video is no longer available per the customer.The safety wire did not release from the stent.A new stent was used and deployed properly as visualized on fluoroscopy." root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to the safety wire becoming trapped between the inner and outer catheter.However, as the device was not returned for evaluation, the cause of this complaint could not be conclusively summary: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Customer complaint is confirmed based on customer testimony.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

As reported to customer relations via phone conversation "the stent would open, but would not deploy.Another g51183-evo-fc-18-23-12-e was opened and used to complete the procedure successfully." patient outcome: did any unintended section of the device remain inside the patient¿s body? - no.If yes, please describe.Did the patient require any additional procedures due to this occurrence? - no.If yes, please describe.Did the product cause or contribute to the need for additional procedures? - no.If yes, please specify additional procedures and provide details.Has the complainant reported any adverse effects on the patient due to this occurrence? - no.Has the complainant reported that the product caused or contributed to the adverse effects? - no.· please specify adverse effects and provide details.Patient/event info - notes: is the patient confirmed covid-19 positive? - per dm, no.(b)(4).Rf (b)(6) 2020.General questions: 1.1.1 at what stage of the procedure did the complaint occur? - the deployment state at the end.When unpacking or preparing the evolution.While inserting the evolution in the patient.During stent placement (this option).While removing the introducer.During stent repositioning/removal.1.1.2 what endoscope type and channel size was used? - olympus 1.1.3 what was the position of the elevator? - they did not use an elevator.They used an upper-scope.Was it opened or closed? - per dm, n/a.1.1.4 details of the wire guide used (diameter, type, make)? - asku.1.1.5 did any part of the stent contact the patient¿s anatomy when the complaint occurred? - yes.1.1.6 how long was the stent in the patient by the time this complaint occurred? - approximately 1 to 2 minutes.1.1.7 for devices where the ifu states for longer term patency has not been established, was periodic evaluation complete and how often? - it never deployed.1.4 questions related to during stent placement: 1.4.1 did the product fail during stent deployment or recapture? - stent deployment.1.4.2 was the directional button pressed during use? - asku.1.4.3 was any part of the stent observed in contact with the patient¿s anatomy at the time of failure? - yes.1.4.4 was the yellow marker kept in view during deployment? - yes.1.4.5 are images of the device or procedure available? - yes.Questions related to during introducer withdrawal 1.5.1 was final stent placement confirmed using endoscopy / fluoroscopy? - there is a video of the flouroscopy.¿ if yes, what was used? - flouroscopy.1.5.2 did the stent open sufficiently to allow withdrawal of introducer safely? - yes.1.5.3 was the safety wire fully removed before removing the delivery system? - yes.1.5.4 did any part of the product snag/get caught with the stent when removing the delivery system? - yes.1.5.5 are images of the device or procedure available? - yes.Can you please provide the video and images? 1.5.1 was final stent placement confirmed using endoscopy / fluoroscopy? - there is a video of the flouroscopy if yes, what was used? - flouroscopy.1.5.5 are images of the device or procedure available? - yes.1.5.4 did any part of the product snag/get caught with the stent when removing the delivery system? ¿ yes.Please elaborate on what part of the product snag/get caught with the stent when removing the delivery system? information from dm: sorry for the confusion, it appears that the video is no longer available per the customer.The safety wire did not release from the stent.A new stent was used and deployed properly as visualized on fluoroscopy.

• Brand Name: EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT -FULLY COVERED
• Type of Device: ESW PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 10199318
• MDR Text Key: 197284577
• Report Number: 3001845648-2020-00373
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002511832
• UDI-Public: (01)10827002511832(17)201120(10)C1560725
• Combination Product (y/n): N
• PMA/PMN Number: K093619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/14/2020

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: 11/20/2020
• Device Model Number: G51183
• Device Catalogue Number: EVO-FC-18-23-12-E
• Device Lot Number: C1560725
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/28/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/02/2020
• Initial Date FDA Received: 06/26/2020
• Supplement Dates Manufacturer Received: 06/02/2020
• Supplement Dates FDA Received: 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1