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

Catalog Number EVO-FC-R-20-25-12-E

Device Problem Migration (4003)

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

Event Date 02/21/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

When the stent was fully released, trying to remove the introducer, the stent migrated.Patient outcome: a section of the device did not remain inside the patient¿s body.The patient did require any additional procedures due to this occurrence.Another stent placement.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence patient/event info - notes: 1.At what stage of the procedure did the complaint occur? while removing the introducer 2.What endoscope type and channel size was used? the stent was placed over the wire 3.What was the position of the elevator? n/a, 4.Details of the wire guide used (diameter, type, make)? standard 0,035" 5.Was the zip port facing upwards and slightly curved when backloading the wire guide? n/a, 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?minutes 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? yes 12.What intervention (if any) was required? another stent placement 13.Was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? same procedure, 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? 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? yes 2.Was resistance felt during insertion into patient? yes 3.If yes, at what point? some normal soft resistance accordind the stricture.Questions related to during stent placement 1.Did the product fail during stent deployment or recapture? other 2.If other, please specify : introducer withdrawal 3.Was the directional button pressed during use? no 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? yes 6.Are images of the device or procedure available? yes, device images were sended.Questions related to during introducer withdrawal 1.Are images of the device or procedure available? yes 2.Was final stent placement confirmed using endoscopy / fluoroscopy? yes 3.If yes, what was used? endoscopy and fluoroscopy 4.Did the stent open sufficiently to allow withdrawal of introducer safely? yes 5.Was the safety wire fully removed before removing the delivery system? yes 6.Did any part of the product snag/get caught with the stent when removing the delivery system? yes.Questions related to during stent repositioning/removal (for evo-fc & evo-pc devices) 1.What instrument was used for stent repositioning / removal? forceps, snare, other n/a.2.If other, please specify.3.Was resistance encountered during advancement and/or deployment? no 4.If yes, please when this was felt? advancement or deployment 5.How did the physician deal with this resistance? 6.Was the lasso (suture) loop used during repositioning n/a.

• 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: 18948202
• MDR Text Key: 339324323
• Report Number: 3001845648-2024-00110
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002551722
• UDI-Public: (01)10827002551722(17)241212(10)C2008933
• Combination Product (y/n): N
• PMA/PMN Number: K093619
• 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: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EVO-FC-R-20-25-12-E
• Device Lot Number: C2008933
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/21/2024
• Event Location: Hospital
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2022
• 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