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 Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Investigation is still pending, a follow-up mdr report will be submitted to include the investigation conclusions.

Event Description

Mdr- 2054 301-032 ae1 -device issues: stent migration, relationship: device; not related, procedure; not relation, pre-existing; no, deficiency: no.Distal stent migration to stomach - endoscopic stent removal.Patient outcome: event: resolved ( patient recovered / stabilized), treatment: endoscopic; study stent removed, death: no.

Manufacturer Narrative

Device evaluation: the device evaluation for evo-fc-r-20-25-8-e of lot c1698036 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 c1698036 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 c1698036 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, states ¿after stent placement, alternative methods of treatment such as chemotherapy and tumour shrinkage should not be administered this may increase risk of stent migration due to tumour shrinkage, stent erosion, and/or mucosal bleeding.¿¿ 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: definitive root cause could not be determined.A possible root cause could be attributed to patient condition as per instructions for use, stent migration is listed as a potential complication following the placement of this device.Confirmation of complaint: complaint is confirmed based on customer and/or rep testimony.Corrective action/ correction: complaints of this nature will continue to be monitored for potential emerging trends.Summary of investigation: according to the customer the stent migrated to the stomach 30 days post stent placement.Confirmed quantity of 1 device, confirmed used.According to the initial report, the stent was removed endoscopically.Investigation findings conclude a definitive root cause was not established.A possible root cause could be attributed to patient condition.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 17-nov-2023.

• 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: 16830472
• MDR Text Key: 314159245
• Report Number: 3001845648-2023-00273
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002551708
• UDI-Public: (01)10827002551708(17)220113(10)C1698036
• Combination Product (y/n): N
• PMA/PMN Number: K093619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/17/2023

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: 01/13/2022
• Device Catalogue Number: EVO-FC-R-20-25-8-E
• Device Lot Number: C1698036
• 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: 04/07/2023
• Initial Date FDA Received: 04/28/2023
• Supplement Dates Manufacturer Received: 04/07/2023
• Supplement Dates FDA Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2020
• 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 Sex: Female
• Patient Weight: 69 KG