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

Model Number ETLW1620C124E

Device Problems Leak/Splash (1354); Migration or Expulsion of Device (1395)

Patient Problem Abdominal Pain (1685)

Event Date 04/08/2024

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: e tbf3220c166e, serial/lot #: (b)(6), ubd: 12-mar-2021, udi#: (b)(4).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.

Event Description

An endurant ii stent graft (etbf3220c166e) and endurant limb (etlw1620c124e) were implanted during the endovascular treatment of a 7 8mm abdominal aortic aneurysm.It was reported approximately 5 years post the index procedure, the patient presented emergently experiencing abdominal pain.A ct scan revealed that both the limbs had pulled into the aneurysm sac causing bilateral type ib endoleaks in etbf3220c166e & e tlw1620c124e. intervention was performed and two additional endurant ii stent graft limbs (etlw1620c156) implanted on the right and (etlw1624c156e) placed on the left were successfully extended to the hypogastric resolving the type ib endoleak. per the physician the cause of the type ib endoleaks was anatomy related due to the patients short common iliac.No additional clinical sequalae were provided and the patient is fine.

Manufacturer Narrative

Film evaluation summary: the reported bilateral type ib endoleak and migration were confirmed on the films provided.Stent migration into the aneurysm sac was most likely a factor in the type ib endoleak, however, the cause of the migration could not be determined from the available films.Lack of pre-implant cts did not allow for assessment of the pre-implant anatomy and earlier pots-implant cts were not available for comparison of the stent graft configuration over time.It is possible that disease progression with aneurysm morphology changes and loss of seal over the duration of implantation of the devices associated with the reported short common iliac arteries may have been a factor in the occurrence of the observed events.Analysis of the returned films did not reveal any out of specification stent graft integrity issues.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
• Type of Device: 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: 19094956
• MDR Text Key: 339982892
• Report Number: 9612164-2024-01762
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00643169467552
• UDI-Public: 00643169467552
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/15/2024

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: 02/27/2021
• Device Model Number: ETLW1620C124E
• Device Catalogue Number: ETLW1620C124E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2024
• Initial Date FDA Received: 04/12/2024
• Supplement Dates Manufacturer Received: 04/18/2024
• Supplement Dates FDA Received: 05/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2019
• 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
• Treatment: "SEE H11...."
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 126 KG