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

Model Number G48033

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/11/2020

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k)#: k162717.Device evaluation: the evo-20-25-15-e device of c1617411 lot number was not returned for evaluation.With the information provided, document based investigation was conducted.Additional information was requested, however due to the current circumstances and restrictions regarding covid-19, only one attempt for additional information has been made.Documents review including ifu review: prior to distribution all evo-20-25-15-e devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.A review of the manufacturing records for evo-20-25-15-e device of lot number c1617411 did not reveal any discrepancies that could have contributed to this issue.There is no evidence to suggest that this issue affects the entire lot #c1617411; upon review of complaints this failure mode has not occurred previously with this lot #c1617411.The instructions for use ifu0061-5 which accompanies this device instructs the user to "when stent point-of-no-return has been passed, pull safety wire out of delivery handle near wire guide port." there is evidence to suggest that the customer did not follow the instructions for use, as per complaint description "the release pin was not pulled before catheter removal." root cause review: a definitive root cause could be determined from the available information.A definitive root cause can be attributed to user error, as the device was not used as per intended use, as per complaint description "the release pin was not pulled before catheter removal." from additional information provided "a second evo esophageal stent was placed with no issue.The stent was used by a dr devadas (surgeon) who took the product from the endoscopy department without consulting any of the endoscopy staff or reps about the product or its use." summary: complaint is confirmed based on the customer's testimony.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Issues with a esophageal stent.Surgeon wanted a 20 fr stent which they took from the endoscopy unit downstairs.The surgeon had never used the cook stents but he said was familiar with the boston scientific ones.While he was deploying it he did experience some difficulty towards the last part of it but then he thought ¿.May be that¿s how it is and then while he was pulling it back the whole stent also came along with it and could not be used anymore.The release pin was not pulled before catheter removal.Patient outcome: did any piece of the device remain inside the patient¿s body? no.Please describe the object and how it was retrieved (if applicable): did the patient require any additional procedures due to this occurrence? no.Did the product cause or contribute to the need for additional procedure(s)? no.Please specify additional procedure(s) and provide details: did the complainant inform of any adverse effect(s) on the patient due to this occurrence? no.Did the complainant inform that the product caused or contributed to the adverse effect(s)? 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: heather ryan ; o halloran road; national technology park; limerick
• MDR Report Key: 10137288
• MDR Text Key: 241745124
• Report Number: 3001845648-2020-00346
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002480336
• UDI-Public: (01)10827002480336(17)210528(10)C1617411
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/12/2020

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: 05/28/2021
• Device Model Number: G48033
• Device Catalogue Number: EVO-20-25-15-E
• Device Lot Number: C1617411
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/11/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/12/2020
• Initial Date FDA Received: 06/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2019
• 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