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

Model Number	ETBF3216C166E
Medical Device Problem Codes	Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Obstruction/Occlusion (2422)
Date of Event	10/29/2015
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 an aaa.6 endoanchors were also implanted.It was reported that the patient rang technical services and stated that post the index procedure, following the implant of the endurant stent grafts, the blood flow was kinked and was being pinched off down towards the leg.The physician implanted a rigid metal stent as intervention.It was confirmed via the sales rep that during the index procedure, a balloon expandable stent was implanted in the left iliac limb secondary to stenosis.At the end of this procedure a possible type ii endoleak was noted.Post follow up with various image modalities showed a possible type ii endoleak.The aneurysm stayed the same size until over six years later where a 1.5 cm increase was then noted.At this time the physician suspected a type 3 leak at the right iliac limbs via ct and a type 1a endoleak via ultrasound scan.The physician discussed possible surgery with the patient but because of the patients parkinson's disease, the patient decided to wait.3 months later, repeat imaging had showed a type 1a endoleak on ct and small increase in aaa diameter.An angiogram was taken which showed type 1a versus type 4.The patient came back in with back pain.It was felt that the pain was musculoskeletal but because of size of the aaa and the known endoleak , treatment was performed.Therefore 10 endoanchors were implanted.2 months later, post op cta showed a type 1a endoleak with aneurysm enlargement.The aneurysm was previously 77mm and then increased to 89mm.Possible surgery for this has been discussed with the patient but the patient has refused.No other endoleak besides this persistent type ia endoleak had been confirmed during patients post-operative follow-ups.The cause of the endoleaks and stenosis/occlusion is unknown per the physician.No additional clinical sequalae were provided and the patient will be monitored.

• Brand Name: ENDURANT II BIFURCATED STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
• 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: 19664243
• Report Number: 9612164-2024-03081
• Device Sequence Number: 6595824
• Product Code: MIH
• UDI-Device Identifier: 00613994990990
• UDI-Public: 00613994990990
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/03/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/14/2017
• Device Model Number: ETBF3216C166E
• Device Catalogue Number: ETBF3216C166E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 07/03/2024
• Date Device Manufactured: 09/15/2015
• 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; Other
• Patient Age: 75 YR
• Patient Sex: Male