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

Catalog Number EVO-20-25-15-E

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 03/25/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The stent could not be deployed, as the trigger got jammed.Patient/event info - notes: query reply: general questions: 1.At what stage of the procedure did the complaint occur? [when unpacking or preparing the evolution, while inserting the evolution in the patient, during stent placement, while removing the introducer, or during stent repositioning/removal] ¿ during stent placement.2.What endoscope type and channel size was used? 3.What was the position of the elevator? [n/a, open, closed].4.Details of the wire guide used (diameter, type, make)? 0.035 inch ¿ sgw guide wire 5.Was the zip port facing upwards and slightly curved when backloading the wire guide? [n/a, yes, no].6.Did any part of the stent contact the patient¿s anatomy when the complaint occurred? [yes].7.Please advise the anatomical location of the intended target site.Esophagus.8.How long was the stent in the patient by the time this complaint occurred? the customer could not recall the time, but said minimal time.9.For devices where the ifu states for longer term patency has not been established, was periodic evaluation completed? [n/a].10.If yes, how often was this completed? 11.Did the patient require any additional procedures as a result of this event? [no].12.What intervention (if any) was required? 13.Was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? [n/a].14.Were any other defects (other than the complaint issue) observed on the device prior to return (e.G.Kink)? [no].15.If yes, please specify what was observed and where on the device it was observed.Stricture information: 1.What was the length and diameter of the stricture? 18 cm.2.Where was the stricture located in the body? esophagus.3.Was there resistance felt passing wire guide through stricture? [no].4.Was there resistance felt passing the evolution through stricture? [yes].5.Was the stricture dilated before stent placement? [no].Questions related to during insertion into patient: 1.Was the product inspected for kinks or damage before use? [no].2.Was resistance felt during insertion into patient? [no].3.If yes, at what point? questions related to during stent placement: 1.Did the product fail during stent deployment or recapture? [deployment].2.If other, please specify.3.Was the directional button pressed during use? [n/a].4.Was any part of the stent observed in contact with the patient¿s anatomy at the time of failure? [yes].5.Was the yellow marker kept in view during deployment? [n/a].6.Are images of the device or procedure available? [no].

• Brand Name: EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY 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: 19173182
• MDR Text Key: 341791786
• Report Number: 3001845648-2024-00187
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002480336
• UDI-Public: (01)10827002480336(17)250104(10)C2013060
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EVO-20-25-15-E
• Device Lot Number: C2013060
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/25/2024
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2023
• 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 Age: 70 YR
• Patient Sex: Male