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

Catalog Number EVO-FC-R-20-25-8-E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation of Esophagus (2399)

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) #: k162717.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

(b)(4).Procedure: were any additional procedure (s) performed during the study procedure? yes - dilation.Were any adverse events documented during the stent procedure? yes.Were any device deficiencies documented during the placement procedure? no.Adverse event #2: perforation of distal esophagus.Adverse event onset (days post stent placement): 0.Event treatment: study stent repositioned.Was the event considered to be related to the study device? related.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? no.Did the event occur due to a device deficiency? no.Event status at time of study exit: resolved (patient recovered/stabilized).

Event Description

This supplemental report is being submitted due to completion of the investigation on the (b)(6) 2023.

Manufacturer Narrative

Pma/510(k) # (b)(4).Device evaluation the device evaluation of evo-fc-r-20-25-8-e lot c1599258 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 c1599258 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 c1599258 confirms the failure mode has not previously occurred for this work order.Instructions for use and/label the instructions for use, ifu0067 which accompanies this device, instructs the user that potential complications associated with upper gi endoscopy include, but are not limited to perforation, haemorrhage; aspiration; reflux; vomiting; fever ; infection; allergic reaction to medication; hypotension; 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 the placement of the study stent.It is known from the available information that the event is related to the study procedure.As per instructions for use, perforation is listed as a complication following the use of this device.Confirmation of complaint is confirmed based on customer and/or rep testimony.Summary of investigation according to the pmcf study perforation of the distal oesophageal occurred in 1 patient during placement of the stent.Confirmed quantity of 1 device, confirmed used.According to the pmcf study, the study stent was re positioned and at the time of the study exit the patient had stabilized/recovered.Investigation findings conclude a possible root cause could be attributed to the placement of the study stent.It is known from the available information that the event is related to the study procedure.As per instructions for use, perforation is listed as a complication following the use of this device.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
• Type of Device: 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: 15914669
• MDR Text Key: 304791039
• Report Number: 3001845648-2022-00827
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002551708
• UDI-Public: (01)10827002551708(17)210328(10)C1599258
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/25/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2021
• Device Catalogue Number: EVO-FC-R-20-25-8-E
• Device Lot Number: C1599258
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/08/2022
• Initial Date FDA Received: 12/05/2022
• Supplement Dates Manufacturer Received: 11/08/2022
• Supplement Dates FDA Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2019
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 80 KG