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

Model Number	G48026
Medical Device Problem Codes	Material Separation (1562); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) #: k163468.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
User release the stent from delivery system while found out the tip of stent has obvious broken.User retracted the stent from patient.User changed to another same device to complete the procedure.Patient outcome: "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.".
Event or Problem Description
Supplemental report is being submitted due to the device evaluated on (b)(6) -2021; "broken shuttle cap and kinked polyimide".
Additional Manufacturer Narrative
Pma/510(k) # - (b)(6).Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Supplemental report is being submitted due to the completion of the investigation.
Additional Manufacturer Narrative
Pma/510(k) #: k163468.Device evaluation: 1 unit of evo-22-27-9-d lot# c1779450 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.Lab evaluation: the device related to this occurrence underwent a laboratory evaluation on the 09 dec 2021.On evaluation of the device the shuttle cap was observed to be broken and the polyimide was kinked.Handle was actuating fine for deployment and recapture but unable to deploy the stent.Handle was opened and the shuttle cap observed broken.Stent deployed manually without any issues.Lock wire removed without any issues.Stent intact.An additional complaint ((b)(4)) was opened to address broken shuttle cap found during lab evaluation.Document review: prior to distribution evo-22-27-9-d devices are subjected to a visual inspection and functional checks to ensure device integrity.A review of the manufacturing records for evo-22-27-9-d of lot number c1779450 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records, confirms the failure mode has or 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 c1779450.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.As noted during the lab evaluation the handle was actuating fine for deployment and recapture but the polyimide was kinked and the shuttle cap was broken.As per engineering input "the fact that the user was able to partially deploy and recapture the stent confirms that shuttle cap was not completely broken and functioning." a possible root cause could be attributed to tortuous patient anatomy.It is possible that during deployment tortuous path may have kinked the polyimide.Summary: the customer¿s testimony could not be confirmed however the complaint is confirmed based on the failure verified in the investigation.The introducer tip was not broken however the polyimide connected to the tip was kinked.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.

• Brand Name: EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED
• Common Device Name: 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: 12834790
• Report Number: 3001845648-2021-00810
• Device Sequence Number: 19965594
• Product Code: MUM
• UDI-Device Identifier: 10827002480268
• UDI-Public: (01)10827002480268(17)221123(10)C1779450
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/09/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/23/2022
• Device Model Number: G48026
• Device Catalogue Number: EVO-22-27-9-D
• Device Lot Number: C1779450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/21/2021
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2021
• Supplement Date Received by Manufacturer: 10/25/2021; 10/25/2021
• Initial Report FDA Received Date: 11/18/2021
• Supplement Report FDA Received Date: 01/06/2022; 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Sex: Male