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

Model Number	G52226
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Type of Reportable Event	Serious Injury
Event or Problem Description
Procedure: was the stent placed at the intended location at completion of the procedure? yes.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.Adverse event: esophagus perforation.Event status at time of study exit: event ongoing.Adverse event onset (days post stent placement): 75.Event treatment: study stent removed.Vac therapy because of anastomsis insufficiency.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: perforation of the esophagus.Was the event considered to be related to the study procedure? related.Did a pre-existing condition, or other condition or circumstance cause or contribute to this event? yes-pec.At the conclusion of follow-up what was the status of the study stent: stent removed endoscopically.Days post stent placement: 86.Reason for removal: stent no longer needed.
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Supplemental follow-up report is being submitted due to the completion of the investigation and an update to the investigation conclusions on the 28-apr-2023.
Additional Manufacturer Narrative
Device evaluation: the device evaluation of evo-fc-20-25-12-e lot c1538706 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.A review of the manufacturing records of lot number c1538706 did not reveal any discrepancies that could have contributed to this complaint issue.Review historical data: the review of relevant manufacturing records of lot number c1538706 confirms the failure mode has not previously occurred for this work order.Instructions for use and/label: the instructions for use, ifu0061 which accompanies this device, instructs the user that potential complications associated with upper gi endoscopy include, but are not limited to perforation, respiratory depression or arrest, cardiac arrhythmia, or arrest.There is no 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 could not be determined from the available information.A possible root cause could be attributed to patient condition.It is known from the available information that the patient has primary oesophageal cancer.The cancer likely contributed to the perforation of the oesophagus.As per instructions for use, perforation is listed as a complication following the use of this device.The stent had to be removed due to the oesophageal perforation.Confirmation of complaint: complaint is confirmed based on customer and/or rep testimony.Summary of investigation: according to the pmcf study perforation occurred in 1 patient 75 days post placement of the esophageal stent.Confirmed quantity of (b)(4) device, confirmed used.According to the pmcf study, the stent was removed endoscopically 86 days post stent placement.Occurrence.The patient with cholecystitis improved with antibiotic treatment.Investigation findings conclude a possible root cause could be attributed to patient condition.It is known from the available information that the patient has primary oesophageal cancer.The cancer likely contributed to the perforation of the oesophagus.As per instructions for use, perforation is listed as a complication following the use of this device.The stent had to be removed due to the oesophageal perforation.Complaint is confirmed based on customer and/or rep testimony.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 LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 15915869
• Report Number: 3001845648-2022-00845
• Device Sequence Number: 11937608
• Product Code: ESW
• UDI-Device Identifier: 10827002522265
• UDI-Public: (01)10827002522265(17)200911(10)C1538706
• 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,Literature
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/11/2020
• Device Model Number: G52226
• Device Catalogue Number: EVO-FC-20-25-12-E
• Device Lot Number: C1538706
• 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
• Initial Report FDA Received Date: 12/05/2022
• Supplement Report FDA Received Date: 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2018
• 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: 76 YR
• Patient Sex: Male
• Patient Weight: 75 KG