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

Model Number	G52227
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Dysphagia/ Odynophagia (1815); Obstruction/Occlusion (2422)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Stent #1: evo-fc-20-25-10-e (c1440187).Procedure: were any additional procedure (s) performed during the study procedure? yes dilation.Were any adverse events documented during the stent procedure? no.Were any device deficiencies documented during the placement procedure? no.Was tumor-reduction therapy documented during follow up? chemotherapy.User error: after stent placement, additional methods of treatment such as chemotherapy and irradiation may increase the risk of stent migration due to tumor shrinkage, stent erosion, and/or mucosal bleeding.Adverse event: stent dislocation + dysphagia adverse event onset (days post stent placement): 50 event treatment: study stent repositioned.Was the event considered to be related to.The study device? related.If related, please provide a detail description of how study device caused or contributed to this event: there was a dislocation of the second stent.After dilatation to 17mm they repositioned the stent and did a fixation with two resolution clips.Was the event considered to be related to the study procedure? related did the event occur due to a device deficiency? yes-dislocation of the stent this file will capture user error, stent dislocation and dysphagia.Patient outcome: at the conclusion of follow-up what was the status of the study stent: stent removed endoscopically.Days post stent placement: 199.Reason for removal: other (unrelated to ae) new stenosis because of hyperplastic tumor tissue.Primary reason for study exit : death.Cause of death: tumor progress.
Event or Problem Description
Supplemental report is being submitted due to the completion of the investigation on 09-mar-2023.
Additional Manufacturer Narrative
Device evaluation: user/use related complaints are considered foreseen misuse.It is unknown how the device will perform outside of instructions for use and/or labelling requirements.The user has not complied with the requirements of the ifu and/label.Trending will monitor if any future investigation is required.The device evaluation could not be completed as the device or photographic evidence of the device was not returned for evaluation.Manufacturing records: prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.There is no evidence to suggest that this issue affects the entire lot #c1509514 upon review of complaints this failure mode has not occurred previously with this lot #c1509514.Instructions for use and/label the instructions for use, which accompanies this device, states ¿after stent placement, alternative methods of treatment such as chemotherapy and radiation should not be administered at this may increase risk of stent migration due to tumour shrinkage, stent erosion, and/or mucosal bleeding.¿¿ there is evidence to suggest that the customer did not follow the instructions for use.Image review: an image was not returned for evaluation.Root cause analysis a definitive root cause of user error was established.The user has not complied with the requirements of the ifu and/label.According to the information available the patient was treated with chemotherapy after stent placement.Summary of investigation complaint is confirmed based on customer and/or rep testimony.According to the initial reporter, the patient did experience adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
Supplemental correction report is being submitted following a review of this complaint file.Updates made were as follows: rpn updated to evo-fc-20-25-12-e, e-code added: e2328, c-code changed: c23, lot number update to c1509514.
Additional Manufacturer Narrative
Supplemental correction report is being submitted following a review of this complaint file.Updates made were as follows: rpn updated to evo-fc-20-25-12-e, e-code added: e2328, c-code changed: c23, lot number update to c1509514.Device evaluation: user/use related complaints are considered foreseen misuse.It is unknown how the device will perform outside of instructions for use and/or labelling requirements.The user has not complied with the requirements of the ifu and/label.Trending will monitor if any future investigation is required.The device evaluation could not be completed as the device or photographic evidence of the device was not returned for evaluation.This file is related to pr(b)(4) #3001845648-2022-00839.Manufacturing records: prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.There is no evidence to suggest that this issue affects the entire lot #c1509514 upon review of complaints this failure mode has not occurred previously with this lot #c1509514.Instructions for use and/label.The instructions for use, ifu0061 which accompanies this device, states ¿after stent placement, alternative methods of treatment such as chemotherapy and radiation should not be administered at this may increase risk of stent migration due to tumour shrinkage, stent erosion, and/or mucosal bleeding.¿¿ there is evidence to suggest that the customer did not follow the instructions for use.Image review: an image was not returned for evaluation.Root cause analysis: a definitive root cause of user error was established.The user has not complied with the requirements of the ifu and/label.According to the information available the patient was treated with chemotherapy after stent placement.Summary of investigation: complaint is confirmed based on customer and/or rep testimony.According to the initial reporter, the patient did experience adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT -FULLY COVERED
• Common Device Name: ESW PROSTHESIS, ESOPHAGEAL
• 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
• MDR Report Key: 15914986
• Report Number: 3001845648-2022-00835
• Device Sequence Number: 6544789
• Product Code: ESW
• UDI-Device Identifier: 10827002522265
• UDI-Public: (01)10827002522265(17)200612(10)C1509514
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K093619
• 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,Followup
• Report Date (Section B): 04/05/2024
• 2 Devices were Involved in the Event: 1 2

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: 06/12/2020
• Device Model Number: G52227
• Device Catalogue Number: EVO-FC-20-25-12-E
• Device Lot Number: C1509514
• 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: 11/08/2022
• Supplement Date Received by Manufacturer: 11/08/2022; 11/08/2022
• Initial Report FDA Received Date: 12/05/2022
• Supplement Report FDA Received Date: 04/06/2023; 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2018
• 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 Age: 53 YR
• Patient Sex: Male
• Patient Weight: 55 KG