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

Model Number G52227

Device Problems Improper or Incorrect Procedure or Method (2017); Migration (4003)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

As reported to customer relations via email "when deploying the stent, the stent would not stay in place." additional information requested.

Manufacturer Narrative

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

Manufacturer Narrative

Cancellation report being submitted.The event does not meet the criteria of an fda ¿serious injury¿ report or ¿malfunction¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016) additional information received on 08-nov-2022 - incorrect size wire guide used.

Event Description

Cancellation report being submitted.The event does not meet the criteria of an fda ¿serious injury¿ report or ¿malfunction¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016) additional information received on 08-nov-2022 - incorrect size wire guide used.Lab evaluation on (b)(6) 2022 visual inspection red marker at first dimple.Pigtail safety wire still in place.Functional inspection: handle actuating fine for deployment and recapture.Stent deployed with no issue.Safety wire removed with no issue.Stent released and intact.As reported to customer relations via email "when deploying the stent, the stent would not stay in place." 1.Did any unintended section of the device remain inside the patient¿s body? · if yes, please describe.No 2.Was the patient hospitalized or was there prolonged hospitalization due to this occurrence? no 3.Did the patient require any additional procedures due to this occurrence? · if yes, please describe.No 4.Did the product cause or contribute to the need for additional procedures? · if yes, please specify additional procedures and provide details.No 5.Has the complainant reported any adverse effects on the patient due to this occurrence? no 6.Has the complainant reported that the product caused or contributed to the adverse effects? · please specify adverse effects and provide details.No 7.Was there any surgical / medical intervention performed due to the experienced difficulty? no intervention was needed, after the stent would not deploy, we were able to remove it and grab a different stent.1.1 general questions: 1.1.1 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 ¿ during stent repositioning/removal 1.1.2 what endoscope type and channel size was used? 1.1.3 what was the position of the elevator? ¿ was it opened or closed? 1.1.4 details of the wire guide used (diameter, type, make)? 1.1.5 did any part of the stent contact the patient¿s anatomy when the complaint occurred? 1.1.6 how long was the stent in the patient by the time this complaint occurred? 1.1.7 for devices where the ifu states for longer term patency has not been established, was periodic evaluation complete and how often? 1.Did any unintended section of the device remain inside the patient¿s body? · if yes, please describe.No 2.Was the patient hospitalized or was there prolonged hospitalization due to this occurrence? no 3.Did the patient require any additional procedures due to this occurrence? · if yes, please describe.No 4.Did the product cause or contribute to the need for additional procedures? · if yes, please specify additional procedures and provide details.No 5.Has the complainant reported any adverse effects on the patient due to this occurrence? no 6.Has the complainant reported that the product caused or contributed to the adverse effects? · please specify adverse effects and provide details.No 7.Was there any surgical / medical intervention performed due to the experienced difficulty? no intervention was needed, after the stent would not deploy, we were able to remove it and grab a different stent.8.What was the date of the event? 9.Will the facility be reporting this event is tothe fda? not that i know of.10.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 ¿ during stent repositioning/removal everything seemed normal up until it was time to deploy the stent.Once the stent was appropriately positioned by the physician and it was time to deploy, i removed the red safety piece under the "trigger," and made sure the "button" on the side of the deployment system was in the correct position to deploy the stent and not in recapture mode.The trigger did not seem to react like normal, it felt like it would not even squeeze to deploy the stent.Also the casing of the deployment system seemed to be separating.Almost like the casing was splitting open slightly.11.What endoscope type and channel size was used? our standard olympus egd scope.1.1.3 what was the position of the elevator? ¿ was it opened or closed? 12.Details of the wire guide used (diameter, type, make)? i believe we used a boston revolution jagwire 0.025 wire.It was that or a cook acrobat 0.025 wire.13.Did any part of the stent contact the patient¿s anatomy when the complaint occurred? yes, the stent was positioned appropriately by the physician, once it would not deploy, it was removed easily without any complications or adverse events for the patient.14.How long was the stent in the patient by the time this complaint occurred? not very long, only a few minutes.15.For devices where the ifu states for longer term patency has not been established, was periodic evaluation complete and how often?.

• 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; holstein campus kiel; arnold- keller str- 3
• Manufacturer Contact: sinead o'leary ; holstein campus kiel; arnold- keller str- 3
• MDR Report Key: 15455496
• MDR Text Key: 306325207
• Report Number: 3001845648-2022-00656
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002522272
• UDI-Public: (01)10827002522272(17)231104(10)C1884099
• Combination Product (y/n): N
• Reporter Country Code: US
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/02/2022

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 Expiration Date: 11/04/2023
• Device Model Number: G52227
• Device Catalogue Number: EVO-FC-20-25-10-E
• Device Lot Number: C1884099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/29/2022
• Initial Date FDA Received: 09/20/2022
• Supplement Dates Manufacturer Received: 08/29/2022
• Supplement Dates FDA Received: 12/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2021
• 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