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

Model Number G48027

Device Problems Activation, Positioning or Separation Problem (2906); Activation Failure (3270)

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

Event Date 10/07/2021

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 opened the package and advanced the delivery system to desired position and released the stent.User detected the delivery system cannot be retracted as expected because it was stuck with released stent under x-ray with unknown reason.User immediately retracted the delivery system along with the stent from patient.Then changed to another same device to complete the procedure."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.

Event Description

Supplemental report required to provide details of device evaluation on (b)(6) 2021."stent fully deployed + damaged.Proximal flexor kinked".

Manufacturer Narrative

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

Manufacturer Narrative

Pma/510(k) # - k163468.Device evaluation: 1 unit of evo-22-27-12-d, lot#: c1702014 involved in this complaint was returned for evaluation, with the original packaging.The packaging was open on receipt.With the information provided, a physical examination and document-based investigation was conducted.Following the review of the complaint image attached to the original complaint information additional information was requested and provided to aid this investigation : " were any other defects (other than the complaint issue) observed on the device prior to return (e.G.Kink)? no.Did the product fail during stent deployment or recapture? stent cannot seperated with sheath.Did any part of the product snag/get caught with the stent when removing the delivery system? yes.What instrument was used for stent removal? forceps, snare¿ stent was retracted along with endoscopy.Lab evaluation : the device related to this occurrence underwent a laboratory evaluation on the 19 nov 2021.On evaluation of the device it was observed the flexor was proximally kinked and the stent was damaged.Safety wire not returned.Stent found to be fully deployed on return and detached from the delivery system.Handle actuation was possible for deployment and recapture.Document review : prior to distribution evo-22-27-12-d devices are subjected to a visual inspection and functional checks to ensure device integrity.A review of the manufacturing records for evo-22-27-12-d of lot number c1702014 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 c1702014.The instructions for use (ifu0053) 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 not sufficient evidence to suggest the user did not follow the ifu.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 compressive forces on the device due to torturous patient anatomy may have resulted in the distal region of introducer catching/snagging the stent upon withdrawal.This torturous path may also have caused a build-up of pressure resulting in the flexor kink observed in the laboratory.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 did not experience any adverse effects due to this occurrence.User immediately retracted the delivery system along with the stent from patient.Then changed to another same device to complete the procedure.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.

• 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; o'halloran road; national technology park; limerick
• Manufacturer Contact: aisling hassett ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 12758503
• MDR Text Key: 285736757
• Report Number: 3001845648-2021-00790
• Device Sequence Number: 1
• Product Code: MUM
• UDI-Device Identifier: 10827002480275
• UDI-Public: (01)10827002480275(17)220123(10)C1702014
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/06/2022

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: 01/23/2022
• Device Model Number: G48027
• Device Catalogue Number: EVO-22-27-12-D
• Device Lot Number: C1702014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/07/2021
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/11/2021
• Initial Date FDA Received: 11/07/2021
• Supplement Dates Manufacturer Received: 10/11/2021; 10/11/2021
• Supplement Dates FDA Received: 12/13/2021; 06/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2020
• 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 Age: 76 YR
• Patient Sex: Male
• Patient Weight: 57 KG