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

Model Number G48027

Device Problems Break (1069); Structural Problem (2506)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.Pma/510(k) #: (b)(4).

Event Description

Inner working of the stent had become detached when deployed.The patient was undergoing a procedure which required them to have a duodenal stent, the procedure was straightforward until placement of the stent it was noted that the inner working of the stent had become detached when the stent was deployed.The scope was carefully removed from the patient and the broken inner catheter of the stent came away attached to the scope.Upon visual examination in the laboratory it was immediately apparent that a piece of the stent mechanism furthest from the handpiece, approximately 26cm long, had become detached from the rest of the device during the procedure.Digital images were taken of the issue as a whole and a close up of the point of detachment has also been included.

Manufacturer Narrative

Pma/510(k) #: (b)(4).Device evaluation the evo-22-27-12-d device of lot number c1700212 involved in this complaint was not available for evaluation.Several attempts were made to obtain additional information regarding this device including whether the device would be returned or not.If it is returned in the future then the file will be updated accordingly.With the information provided, a document-based investigation was conducted.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 c1700212 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 c1700212.The instructions for use (ifu0053-9) 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" and "after deployment, fluoroscopically confirm full stent expansion.Once full expansion is confirmed, introduction system can be safely removed." 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 from the available information.A possible root cause could be attributed to torturous patient anatomy.It is possible that during deployment tortuous path may have caused a build-up of pressure resulting in the polyimide break.However, as the device was not returned for evaluation; the cause of this complaint could not be conclusively determined.Summary the complaint is confirmed based on customer testimony.There were no adverse effects to the patient reported due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental report is being submitted due to completion of 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 LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: aisling hassett ; o halloran road; national technology park; limerick
• MDR Report Key: 11928552
• MDR Text Key: 255143239
• Report Number: 3001845648-2021-00430
• Device Sequence Number: 1
• Product Code: MUM
• UDI-Device Identifier: 10827002480275
• UDI-Public: (01)10827002480275(17)220120(10)C1700212
• 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
• Type of Report: Initial,Followup
• Report Date: 01/12/2022

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: 01/20/2022
• Device Model Number: G48027
• Device Catalogue Number: EVO-22-27-12-D
• Device Lot Number: C1700212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/05/2021
• Initial Date FDA Received: 06/03/2021
• Supplement Dates Manufacturer Received: 05/05/2021
• Supplement Dates FDA Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2020
• 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