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 Information (3190); Insufficient Information (4580); 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.

Event Description

Examination in the lab confirmed the defect report.The smtl received on 7th august 2020 one putative defective cook medical evolution duodenal stent, size 12cm * 10fr catalogue number evo-22-27-12, lot number c1700212.The accompanying defect reporting form sent in by unit manager (b)(6), on behalf of consultant gastroenterologist (b)(6), endoscopy, (b)(6), stated: "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 of the scope.Upon visual examination in the laboratory it was immediately apparent that a piece of the stent mechanism furthest form the handpiece, approximately 26 cm 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.In this instance, to enable manufacturers to examine the device in the received state, decontamination has not been performed, as thus we are unable to sent it through the post.We will retain the device at smtl for 8 weeks from the date of the report despatch, after which it will be incinerated.If you wish to collect the device from smtl within this period, please contact us to arrange this.

Manufacturer Narrative

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

Event Description

Follow up report required to capture the below additional information: device evaluated on (b)(6) 2021: "polyimide to retrieval loop broken.Yellow marker separated/detached".

Manufacturer Narrative

Pma/510(k) #: k163468.Device evaluation: (b)(4) unit of evo-22-27-12-d lot# c1700212 involved in this complaint was returned for evaluation, without the original packaging.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 14 apr 2021.On evaluation of the device the polyimide to retrieval loop was found broken and the yellow marker was separated/detached.The polyimide, yellow marker and lock wire were all returned separately.Stent was not returned.The handle was actuating fine for deployment and retraction.Document review: prior to distribution 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 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 ifu0053-10 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 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 excessive force applied to the device, potentially causing the joint breakage between the polyimide and peek tubing or as a result of tortuous patient anatomy.Summary: complaint is confirmed as the failure was verified in the laboratory.The patient outcome is unknown.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 LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: aisling hassett ; o halloran road; national technology park; limerick
• MDR Report Key: 11176441
• MDR Text Key: 227897016
• Report Number: 3001845648-2021-00019
• 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,Followup
• Report Date: 10/20/2021

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: 01/20/2022
• Device Model Number: G48027
• Device Catalogue Number: EVO-22-27-12-D
• Device Lot Number: C1700212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/18/2020
• Initial Date FDA Received: 01/15/2021
• Supplement Dates Manufacturer Received: 12/18/2020; 12/18/2020
• Supplement Dates FDA Received: 05/12/2021; 11/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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