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

Model Number G48026

Device Problems Material Separation (1562); Device Damaged Prior to Use (2284)

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

Event Date 09/29/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

"tip is mangled.Did not make patient contact, and was observed upon removal from the packaging.User opened another of the same gpn to proceed." 1.Did any unintended section of the device remain inside the patient¿s body? no ¿ if yes, please describe.2.Was the patient hospitalized or was there prolonged hospitalization due to this occurrence? no ¿ if yes, please describe.3.Did the patient require any additional procedures due to this occurrence? no ¿ if yes, please describe.4.Did the product cause or contribute to the need for additional procedures? no ¿ if yes, please specify additional procedures and provide details.5.Has the complainant reported any adverse effects on the patient due to this occurrence? no 6.Has the complainant reported that the product caused or contributed to the adverse effects? no ¿ please specify adverse effects and provide details.

Manufacturer Narrative

510(k) number: k163468.Device evaluation the evo-22-27-9-d device of lot number c1840955 involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.As per image provided the polyimide appears to be acutely kinked/damaged within the introducer.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 c1840955 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 c1840955.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 an 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 from the available information.A possible root cause could be attributed to transportation, storage facilities or handling of the device during removal from packaging.It is possible that handling of the tip while removing from the packaging could have led to the kink/damage to the polyimide.Summary: the complaint is confirmed based on customer testimony.According to the initial reporter, the device did not make patient contact and was observed upon removal from the packaging.Patient did not experience any adverse effects 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 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: 12710556
• MDR Text Key: 284687106
• Report Number: 3001845648-2021-00747
• Device Sequence Number: 1
• Product Code: MUM
• UDI-Device Identifier: 10827002480268
• UDI-Public: (01)10827002480268(17)230617(10)C1840955
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/09/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 06/17/2023
• Device Model Number: G48026
• Device Catalogue Number: EVO-22-27-9-D
• Device Lot Number: C1840955
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/29/2021
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/29/2021
• Initial Date FDA Received: 10/28/2021
• Supplement Dates Manufacturer Received: 09/29/2021
• Supplement Dates FDA Received: 04/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2021
• 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