MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDURANT II ILIAC STENT GRAFT; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	ETLW1620C124E
Medical Device Problem Codes	Difficult to Remove (1528); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
An endurant ii stent graft etlw1620c124e limb was implanted during the endovascular treatment of a 40mm aaa.It was reported that during the index procedure, after deployment of the stent graft the trigger on the delivery system would not move and was jammed.The physician was unable to join the grey slider to the blue trigger handle.The physician was able to remove the delivery system without patient injury despite this.It was confirmed the deployment itself went fine.Per the physician the cause of the removal difficulty could not be determined.No additional clinical sequalae were provided and the patient is fine.
Additional Manufacturer Narrative
Film evaluation summary: the reported "difficult to remove" of the endurant iliac delivery system could not be assessed on the pre-implant films provided, therefore a cause can not be established.Lack of provision of procedural images showing the deployment of the stent graft and removal of the delivery system means that the reported removal difficulties event cannot be assessed.An unknown procedural or possible device issue cannot be ruled out as a potential cause.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Product analysis device returned with the external slider in the open position.An excessive kink was visible on the graft cover distal to strain relief due to folding of the device to return.The external slider was rotated, and the graft cover was retracted and advanced with no resistance noted.Resistance was noted retracting the trigger.The trigger did not return to the home position when released after activation.There was no damage evident to the screw gear threads which would have hindered movement of the slider.The external slider was disassembled.The trigger sleeve did not return to the home position.The end of the spring was trapped between the trigger sleeve and the inner slider.Longitudinal scratches were visible on the inner sider.On removal of the spring from between the sleeve and inner slider no resistance was noted retracting and advancing the trigger.The reported removal difficulties were confirmed through analysis.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: ENDURANT II ILIAC STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 20125061
• Report Number: 9612164-2024-04022
• Device Sequence Number: 7462719
• Product Code: MIH
• UDI-Device Identifier: 00643169467552
• UDI-Public: 00643169467552
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/18/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2026
• Device Model Number: ETLW1620C124E
• Device Catalogue Number: ETLW1620C124E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2024
• Supplement Date Received by Manufacturer: 10/25/2024; 12/18/2024
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 11/15/2024; 12/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Male