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

Model Number	G48032
Medical Device Problem Codes	Activation Failure (3270); Activation Problem (4042)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) #: k162717.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
"i contacted the pharmacist mr (b)(6), who confirms the placement of three prostheses on the same patient; (b)(4) - the first did not open, it is a complaint [this medwatch report] (b)(4) - the second has moved but it is not complaint, it is a failure to placed- echec de pose ( usually manupilation issue by doctor or patient anatomy but not related to the product it self ) the third was placed ( no issue there)" additional information has been requested but to date no details have been received indicating adverse effects to the patient.
Additional Manufacturer Narrative
Pma/510(k) #: k162717.Device evaluation the evo-20-25-12.5-e device of lot number c1789114 involved in this complaint has not yet been returned for evaluation.Several attempts were made to obtain additional information regarding this device.However, no response has been received to date.If the device is returned in the future then the file will be updated accordingly.With the information provided, a document-based investigation was conducted.The investigation will be updated once the device has been returned and evaluated.Document review prior to distribution evo-20-25-12.5-e devices are subjected to a visual inspection and functional checks to ensure device integrity.A review of the manufacturing records for evo-20-25-12.5-e of lot number c1789114 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 c1789114.It should be noted that the instructions for use (ifu0061-7) states the following: "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 no evidence to suggest that the customer did not follow the instructions for use.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to tortuous patient anatomy, however, as the device was not returned for evaluation and additional questions were not answered; the cause of this complaint could not be conclusively determined.Summary: customer complaint is confirmed based on customer testimony.From the information provided it is unknown whether the patient experienced any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.Note that this file is related to pr 331733 (3001845648-2021-00389) (stent migration).
Event or Problem Description
Supplemental report is being submitted due to the completion of the investigation.

• 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: aisling hassett ; o halloran road; national technology park; limerick
• MDR Report Key: 11825016
• Report Number: 3001845648-2021-00388
• Device Sequence Number: 14452508
• Product Code: ESW
• UDI-Device Identifier: 10827002480329
• UDI-Public: (01)10827002480329(17)230105(10)C1789114
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/05/2023
• Device Model Number: G48032
• Device Catalogue Number: EVO-20-25-12.5-E
• Device Lot Number: C1789114
• 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: 04/26/2021
• Supplement Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 04/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2021
• 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
• Patient Sex: Unknown