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

Model Number G48027

Device Problem Break (1069)

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

Event Date 11/12/2020

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

Than it says that it is a minor incident.The stent did not deploy because the catheter broke during procedure."as per cc form": when nurse tried to deploy the stent she felt the handle very hard to press and then they heard a big "crack" and then stent did not want to deploy, surgeon removed the system and checked it on table and he realised that the catheter was broken.Patient is fine.Device evaluated 26-nov-2020: "flexor broken at 28cm from distal tip.Unable to deploy stent due to break".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.Endoscope type and channel size was used? not communicated.What was the position of the elevator? was it opened or closed? closed.Details of the wire guide used (diameter, type, make)? 035 jagwire.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? around 10%.For devices where the ifu states for longer term patency has not been established, was periodic evaluation complete and how often? not applicable.Is the patient known to be covid-19 positive? not positive stricture information: what was the length and diameter of the stricture? not communicated.Where was the stricture located in the body? duodenum.Was there resistance felt passing wire guide through stricture? no.Was there resistance felt pass1.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 deployinging 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 and all was ok.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? yes.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? 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? this stent was not placed at final.Did the stent open sufficiently to allow withdrawal of introducer safely? complete device was removed.Was the safety wire fully removed before removing the delivery system? not removed as stent not deployed in patient.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.Not applicable.

Event Description

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

Manufacturer Narrative

Pma/510(k) #: k163468.Device evaluation: the evo-22-27-12-d device of lot number c1733136 involved in this complaint device was returned for evaluation, was returned in the original pouch.With the information provided, a physical examination and document based investigation was conducted.Lab evaluation: the device involved in the complaint was evaluated in the laboratory on 26th november 2020.In summary the following results were observed in the lab evaluation: flexor was found to be broken approximately 28cm from distal tip.Red marker on top of the introducer at start of the handle, kink in the clear part of the flexor.Lock wire in place on return.Actuation of handle was possible without any difficulties but unable to deploy the stent due to the flexor break.Handle was opened and all components were intact.Lab notes and images attached.Following the lab evaluation an additional information was requested to aid with this investigation: -was the device in the tortuous position at any stage during the procedure? "when i asked dr lefebvre, he said no.He said it was a procedure like another procedure the second stent used was fine and procedure easy done and finished.Documents review including ifu review: prior to distribution all evo-22-27-12-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-22-27-12-d device of lot number c1733136 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 #c1733136; upon review of complaints this failure mode has not occurred previously with this lot #c1733136.The instructions for use ifu0053-10 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.Although it has been advised the device wasn¿t in tortuous path, it is possible the actual patient anatomy was tortuous as the type of procedure was stenosis on duodenum.Additionally it is possible that excessive force was applied during procedure, as there was a kink evident in the clear part of the flexor which could indicate that some force may have been applied at some stage.Also it may be possible that the user did not fully engage the directional button for deployment, as per additional information provided the directional button was not pressed during use.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.

• 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
• MDR Report Key: 10987981
• MDR Text Key: 253110859
• Report Number: 3001845648-2020-00933
• Device Sequence Number: 1
• Product Code: MUM
• UDI-Device Identifier: 10827002480275
• UDI-Public: (01)10827002480275(17)220518(10)C1733136
• Combination Product (y/n): N
• 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: 03/05/2021

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: 05/18/2022
• Device Model Number: G48027
• Device Catalogue Number: EVO-22-27-12-D
• Device Lot Number: C1733136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/12/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/12/2020
• Initial Date FDA Received: 12/10/2020
• Supplement Dates Manufacturer Received: 11/12/2020
• Supplement Dates FDA Received: 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1