MAUDE Adverse Event Report: Endologix Santa Rosa Ovation iX; Main Body

Model Number	TV-AB2980-J
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	09/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) on (b)(6) 2019 with the implant of an alto abdominal stent graft system.Routine follow-up conducted on approximately on (b)(6) 2026 identified a type ia endoleak.Patient currently has no symptoms and was being monitored with a re-intervention scheduled; however, the re-intervention procedure was cancelled as the patient¿s family decided not to do anything.
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation and remain implanted in the patient.Patient medical records have been received and medical imaging studies have been requested for further evaluation by a clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.

• Brand Name: Ovation iX
• Common Device Name: Main Body
• Manufacturer (Section D): Endologix Santa Rosa; 3910 brickway blvd; santa rosa CA 95403
• Manufacturer (Section G): Endologix Santa Rosa; 3910 brickway blvd; ,; santa rosa CA 95403
• Manufacturer Contact: gary kirchgater ; 3910 brickway blvd; ,; santa rosa, CA 95403 ; +1(800)983-2284
• MDR Report Key: 50899768
• Report Number: 3008011247-2026-00106
• Device Sequence Number: 6001697
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2980J1
• UDI-Public: +M701TVAB2980J1/$$3211206FS1127181441
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/06/2021
• Device Model Number: TV-AB2980-J
• Device Lot Number: FS112718-41
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CustomSeal Kit Fill Polymer (lot#: FF080317-01).; Ovation iX Iliac Limb (lot#: FS041218-21).; Ovation iX Iliac Limb (lot#: FS090418-34).
• Outcome Attributed to Adverse Event: Other
• Patient Age: 89 YR
• Patient Sex: Male