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); Activation, Positioning or Separation Problem (2906)

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

Event Date 03/18/2022

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

Excerpted from customer's email to the rep: we attempted to use the 12cm duodenal stent 10fr today however we were unable to deploy the stent.It was noted that covering just above the distal tip of the stent was not intact.Taken from the complaint form: during the procedure, no guide wire was placed.The duodenal 12cm stent was positioned in the duodenum.However; deployment was stopped as the team felt there was an issue deploying the stent.As the 12cm duodenal stent was not fully deployed, it was removed without incidence still attached to the delivery mechanism.Another 9cm duodenal stent product code evo-22-27-9-d lot c1878169.Was implanted instead without any difficulty.No unintended part of the device remained inside the patient's body.No additional procedure was required due to this occurrence.No adverse effect on the patient was reported due to this occurrence.

Manufacturer Narrative

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

Event Description

Supplemental report is being submitted due to the completion of a lab evaluation on 09 may 2022: visual inspection: stent partially deployed on return, broken flexor at clear section , wire guide still in place on return functional inspection: handle actuating fine but not able to deploy the stent.

Event Description

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

Manufacturer Narrative

Pma/510(k) # k163468.Device evaluation 1 unit of evo-22-27-12-d lot#c1891739 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 09th may 2022.On evaluation of the device the following was observed.Lab evaluation date: 09 may 2022 visual inspection: stent partially deployed on return, broken flexor at clear section , wire guide still in place on return functional inspection: handle actuating fine but not able to deploy the stent.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 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 c1891739.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 a tortuous path may have caused a build-up of pressure resulting in the flexor break.Additionally, it is possible that excessive force was applied during procedure.Summary complaint is confirmed as the failure was verified in the laboratory.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
• Type of Device: MUM STENT, METALIC EXPANDABLE, DUODENAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND; holstein campus kiel; arnold- keller str- 3; limerick
• Manufacturer Contact: sinead o'leary ; holstein campus kiel; arnold- keller str- 3; limerick ; 061334440
• MDR Report Key: 14102911
• MDR Text Key: 298708180
• Report Number: 3001845648-2022-00225
• Device Sequence Number: 1
• Product Code: MUM
• UDI-Device Identifier: 10827002480275
• UDI-Public: (01)10827002480275(17)231130(10)C1891739
• 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: 07/01/2022

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: 11/30/2023
• Device Model Number: G48027
• Device Catalogue Number: EVO-22-27-12-D
• Device Lot Number: C1891739
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/18/2022
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/22/2022
• Initial Date FDA Received: 04/13/2022
• Supplement Dates Manufacturer Received: 03/22/2022; 03/22/2022
• Supplement Dates FDA Received: 06/03/2022; 07/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2021
• 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