MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED; ESW PROSTHESIS, ESOPHAGEAL

Model Number	G48032
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pma/510(k) # k162717.Investigation is still pending, a follow-up mdr report will be submitted to include the investigation conclusions.
Event or Problem Description
Mdr- 2054 301-047 ae1 - device issues: stent migration, relationship: device; not related, procedure; not related, pre-existing: no.The device was placed but quickly migrated to the stomach.A new one was placed.Another stent had to be placed in its place due to migration of the first one.Patient outcome: status: resolved ( patient recovered / stabilized), treatment endoscopic new stent placed (non-study stent); cook evolution, death: no.
Additional Manufacturer Narrative
Pma/510(k) # (b)(4).Evice evaluation the 1x evo-20-25-12.5-e device of lot number c951107 involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.Lab evaluation the device lab evaluation could not be completed as the device, or photographic evidence of the device, was not returned for evaluation.Document review prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records did not reveal any discrepancies that could have contributed to this complaint issue.Historical data review the review of relevant manufacturing records confirms the failure mode has not previously occurred for this work order.Ifu & label review as per the ifu (ifu0061), stent migration is a known potential adverse event associated with gi endoscopy ¿additional complications include, but are not limited to: stent misplacement and/or migration¿ there is no evidence to suggest that the customer did not follow the instructions for use or product label.Image review an image was not returned for evaluation.Root cause review a definitive root cause could not be determined from the available information.A possible root cause could be attributed to the procedure performed on the patients as it is known, as per the ifu, that stent migration is a known potential adverse event associated with gi endoscopy.Summary according to the pmcf study, the evo-20-25-12.5-e stent was placed but quickly migrated to the stomach.The migration occurred 0 days post-placement.Confirmed quantity of 1 device.Confirmed used.As a result of this occurrence, the patient did experience an adverse effect.To treat the stent migration, the patient required a non-study stent to be placed endoscopically.The patient recovered/stabilized after treatment.Investigation findings concluded a definitive root cause could not be determined.A possible root cause could be attributed to the procedure as stent migration is a known potential adverse event associated with upper gi endoscopy as per the ifu.Complaint is confirmed based on customer and/or rep testimony.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
Supplement follow-up report is being submitted due to the completion of the investigation on (b)(6) 2023 and an update to the investigation conclusions.

• Brand Name: EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED
• Common Device Name: ESW PROSTHESIS, ESOPHAGEAL
• 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: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 16830476
• Report Number: 3001845648-2023-00276
• Device Sequence Number: 1855442
• Product Code: ESW
• UDI-Device Identifier: 10827002480329
• UDI-Public: (01)10827002480329(17)151203(10)C951107
• 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: Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/03/2015
• Device Model Number: G48032
• Device Catalogue Number: EVO-20-25-12.5-E
• Device Lot Number: C951107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/11/2023
• Supplement Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 06/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male