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

Model Number ETLW1620C124EE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Ischemia (1942); Hematemesis (4478); Melena (4480)

Event Date 01/03/2024

Event Type  Death  

Manufacturer Narrative

Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: e tlw1620c124ee, serial/lot #: (b)(6), ubd: 31-mar-2024, 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 iis stent graft system was implanted during endovascular treatment of an abdominal aortic aneurysm.Esbf3214c103ee was s uccessfully implanted, followed by etlw1620c124ee positioned proximal to the right internal iliac artery, etlw1620c124ee positioned proximal to left internal iliac artery.Two reliant stent graft balloons were utilized to enhance contact between the stent grafts and the vessel walls of the left and right endurant limbs.It was reported approximately 2 years post the index procedure, the patient was hospitalized due to symptoms of vomiting blood and melena.The patient was treated with a blood transfusion and medication.Gastroscopy revealed no identifiable cause of the bleeding.Colonoscopy showed ischemic colitis.Ct imaging showed an increase in the aneurysm sac to 118mm due to a type ii endoleak.Air detected in the aneurysm sac concluded an infected sent.The duodenum lay tightly over the aneurysm sac, which had the potential to cause a fistula due to the infected sac.A type i endoleak was noted cranially in the aneurysm sac.No surgical intervention was possible due to the patients age and calcified aorta.The patient was discharged from the hospital 5 days after admission under palliative care.The patient expired one day post discharge.No specific cause of death was provided.The site assessed the infected aneurysm sac, type i and type ii endoleaks as possible related to the endurant devices and not related to the index procedure.

Manufacturer Narrative

Additional information received: the sponsor assessed the infected aneurysm sac as not related to the index procedure and possible device related.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.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: 18948798
• MDR Text Key: 338229633
• Report Number: 9612164-2024-01376
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/22/2024

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/19/2024
• Device Model Number: ETLW1620C124EE
• Device Catalogue Number: ETLW1620C124EE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 03/21/2024
• Supplement Dates Manufacturer Received: 03/21/2024
• Supplement Dates FDA Received: 03/22/2024
• Date Device Manufactured: 04/20/2022
• 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): Death
• Patient Sex: Male
• Patient Weight: 73 KG