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

Model Number	ESBF2814C103E
Medical Device Problem Codes	Leak/Splash (1354); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Aneurysm expansion (4597)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
An endurant iis stent graft system was implanted during the endovascular treatment of a aaa.It was reported that multiple type ii endoleaks were observed and the patient underwent multiple endovascular interventions including lumbar embolization and coiling of the left hypo with extension into the left eia eight years later.It was reported that about 18 months ago the patient underwent an ir embolization of a median sacral artery.There was another possible type ii endoleak from an l3 lumbar artery that the physician couldn't access at that time.A cta taken showed stable sac size but persistent endoleak.The patient went back for additional ir embolization of the ima and the l3 lumbar.A cta taken six months later showed stable sac with persistent endoleak.A non-contrast ct five months later showed stable sac size.A cta taken 10 years post the index procedure showed increased sac size, a new type ia endoleak, and suprarenal stent separation.No issues were noted with the endurant illiac limbs.The patient was then admitted with abdominal pain and further sac enlargement and underwent open explant and repair.The suprarenal fixation was completely separated from the rest of the main body and the proximal end of the main body was floating freely in the sac.The physician noted the graft was cleanly separated circumferentially along the edge of the fabric.The physician left the suprarenal fixation in place, explanted the main body and the contra limb, and sewed the remaining iliac limbs with a bifurcated non-mdt graft and felt.The physician believed the separation was due to a complete lack of proximal seal zone fabric contact with the aorta due to the ongoing aaa growth from the type ii endoleaks.It was commented that at some point the graft as hanging in the aaa sac from the suprarenal stent.No additional clinical sequalae were provided and the patient is fine.
Additional Manufacturer Narrative
Product analysis a section of an endurant bifurcate graft was received for analysis.Suprarenal struts detached prior to receipt of device and were not received for analysis.Tearing was evident to the distal edge of the graft at the detachment site.Small holes (2mm²) and fabric wear to distal graft.A hole approximately 3mm² was evident between stent ring (sr) 3 sr4.Abrasion was evident between sr3 and sr4.Trainwrecking was evident to both legs.A cut or tear was evident between sr9 and sr10 on the ipsilateral leg.No other issues were evident to the remainder of the graft.Image analysis three still images were received for analysis.First image depicts 3 explanted stent grafts, a bifurcate and 2 limbs.The suprarenal struts appear to have detached from the bifurcate.Second and third image depict the explanted bifurcate graft held in a gloved hand.The suprarenal struts appear to have detached.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 IIS BIFURCATED 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: 22011329
• Report Number: 9612164-2025-02355
• Device Sequence Number: 5192277
• Product Code: MIH
• UDI-Device Identifier: 00643169439979
• UDI-Public: (01)00643169439979(17)170114(21)V06008790
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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
• Report Date (Section B): 06/30/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/14/2017
• Device Model Number: ESBF2814C103E
• Device Catalogue Number: ESBF2814C103E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2025
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2015
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Unknown
• Patient Weight: 58 KG