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 Improper or Incorrect Procedure or Method (2017)

Patient Problems Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

Stent #3: evo-fc-r-20-25-8-e (b)(4).Procedure: was the stent placed at the intended location at completion of the procedure? yes.Location of distal end of stent? distal to placed stent #2.Were any additional procedure (s) performed during the study procedure? no.Were any adverse events documented during the stent procedure? no.Were any device deficiencies documented during the placement procedure? no.User error: incorrect stent size used.It was later found that the diameter of the esophagus is greater than stent.Adverse event onset (days post stent placement) 7.Endoscopic treatment: study stent removed.Medical treatment: nasogastric tube.Was the event considered to be related to the study device? related.Was the event considered to be related to the study procedure? not related.Did a pre-existing condition, or other condition or circumstance cause or contribute to this event? no.Did the event occur due to a device deficiency? no.

Manufacturer Narrative

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

Manufacturer Narrative

Device evaluation: user/use related complaints is considered foreseen misuse.It is unknown how the device will perform outside of instructions for use and/or labelling requirements.The user has not complied with the requirements of the ifu and/label.Trending will monitor if any future investigation is required the device evaluation for evo-fc-r-20-25-10-e of lot c1589858 could not be completed as the device or photographic evidence of the device was not returned for evaluation.Manufacturing records: prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records of lot number c1589858 did not reveal any discrepancies that could have contributed to this complaint issue.Review historical data: the review of relevant manufacturing records of lot number c1589858 confirms the failure mode has not previously occurred for this work order.Instructions for use and/label : the instructions for use which accompanies this device, instructs the user that:¿¿ a complete diagnostic evaluation must be performed prior to use to determine proper stent size.¿¿ there is evidence to suggest that the customer did not follow the instructions for use.Image review: an image was not returned for evaluation.Root cause analysis.A definitive root cause was established.The customer has chosen the incorrect stent size, from the available information it is known that stent size chosen was smaller than the diameter of the oesophagus.The instructions for use which accompanies this device, instructs the user that:¿¿ a complete diagnostic evaluation must be performed prior to use to determine proper stent size.¿¿ confirmation of complaint.Complaint is confirmed based on customer testimony.Summary of investigation.According to the customer the incorrect stent size was used.Confirmed quantity of 1 device, confirmed used.According to the initial report the stent was endoscopically removed 52 days post placement.Investigation findings conclude definitive root cause was established.The customer has chosen the incorrect stent size, from the available information it is known that stent size chosen was smaller than the diameter of the oesophagus.The instructions for use which accompanies this device, instructs the user that:¿¿ a complete diagnostic evaluation must be performed prior to use to determine proper stent size.¿¿ complaint is confirmed based on customer testimony.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental follow-up mdr report is being submitted due to the completion of the investigation and an update to the investigation conclusions.

• 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: 15923155
• MDR Text Key: 304873182
• Report Number: 3001845648-2022-00846
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002551708
• UDI-Public: (01)10827002551708(17)210227(10)C1589858
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K093619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2021
• Device Catalogue Number: EVO-FC-R-20-25-10-E
• Device Lot Number: C1589858
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/08/2022
• Initial Date FDA Received: 12/06/2022
• Supplement Dates Manufacturer Received: 11/08/2022
• Supplement Dates FDA Received: 06/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2019
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Weight: 145 KG