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 Migration (4003)

Patient Problems Dysphasia (2195); Weight Changes (2607); Decreased Appetite (4569)

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

Device issue: stent migration, endoscopy distal, to stomach.No other: high mobility from oesophagus, yes.Dysphagia.Yes.Relationship device: no, procedure; no, pre-existing condition; yes.No.(b)(6).(b)(6).(b)(6).Symptoms pre procedure: dysphagia.Loss of appetite.Weight loss.1 day post procedure: distal stent migration to stomach confirmed by endoscopic imaging.Stent repositioned endoscopically.Patient outcome : status: resolved.Treatment: endoscopy; study stent repositioned.Death: no.Patient/event info: ae # this form is in relation to (b)(6) (b)(6) 2023 09:50:26 ct (b)(6).N/a change no.Query.Note: transcription error.Days post procedure 1 (b)(6) 2023 09:57:17.Ct (b)(6).N/a change no.Query.Note: question value '73' updated to '1' based on data value advice edit check opdays_dva_2.

• 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: 18370882
• MDR Text Key: 331047422
• Report Number: 3001845648-2023-00939
• 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