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

Catalog Number EVO-FC-R-20-25-10-E

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Dysphasia (2195)

Event Type  Injury  

Event Description

Device issue: stent migration; endoscopy distal; to stomach, no, reduction in tumor size.Relationship: device: no, procedure: no.Pre-existing: yes; chemo lead to tumor mass reduction.Deficiency: no mdr2054 ae2 - patient (b)(6) resume oral intake within 24hours procedure.No dysphagia score documented during follow up proton pump inhibitor being administered.Tumour reduction therapy administered in follow up¿ chemo day 73 (after placement): stent migration distally to stomach removal of stent as no longer required patient outcome: status: resolved.Treatment: endoscopy; study stent removed.Death: no.

Manufacturer Narrative

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

• 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: 18380119
• MDR Text Key: 331184594
• Report Number: 3001845648-2023-00940
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002551715
• UDI-Public: (01)10827002551715(17)200731(10)C1524773
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: EVO-FC-R-20-25-10-E
• Device Lot Number: C1524773
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 73 KG