MAUDE Adverse Event Report: ENDOLOGIX SANTA ROSA ALTO; MAIN BODY

Model Number	TV-AB3480-N
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Clinical Endoleak (4843)
Date of Event	08/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.An evaluation of the manufacturing record was completed.A review of the part number/lot number combination needed for device identification shows the device to have been properly manufactured and released in accordance with the device master record.The review confirms there were no manufacturing or processing non-conformities identified that would contribute to the reported adverse event/incident.An evaluation of the device could not be completed.The device was not returned to endologix for evaluation because it remains implanted.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows that the implant migration, type ia endoleak and right renal artery occlusion complaints are unconfirmed.The additional endovascular procedure complaint is confirmed.This is moderately consistent with the reported adverse event/incident.It was reported that approximately 30 days post-index procedure, the right renal artery stent occluded due to thrombus and was treated with renal chimney stent thrombectomy and distal stent extension.The implant migration and type ia endoleak was reported as potentially iatrogenic during this intervention (thrombectomy); however, this could not be conclusively determined.Device, user, procedure or anatomy relatedness of complaint cannot be determined.Procedure related harms cannot be determined.A planned discharge on postoperative day one following the secondary procedure was reported; however, the final patient status was not stated.No additional investigation of this reported adverse event/incident is planned.However, should additional information relevant to the investigation outcome become available, a follow-up report will be submitted.Endologix will continue to monitor this and similar adverse events/incidents.
Event or Problem Description
The patient was implanted with the alto stent graft system with a right renal chimney stent (non endologix) on (b)(6) 2024 for treatment of an abdominal aortic aneurysm (aaa).Thirty days post procedure, the right renal stent became occluded.The patient was admitted, and the right renal chimney was accessed from the groin, followed by percutaneous mechanical thrombectomy.The chimney stent (non endologix) was subsequently extended distally.Due to procedural manipulation, the alto main body shifted, resulting in a type ia endoleak identified on the final angiogram.The patient was discharged given the high contrast load and the temporary period of renal malperfusion.A computed tomography (ct) scan was performed at the end of (b)(6) 2026.On (b)(6) 2026, the patient underwent reintervention.Medtronic endurant aortic cuff (non endologix), a right renal periscope stent (non endologix), a left renal chimney stent (non endologix), and coil embolization of the aneurysm sac (non endologix) were placed.The type ia endoleak was successfully resolved.The patient has remained asymptomatic throughout the course of treatment, with the exception of the initial renal stent occlusion.Following the procedure, the patient was transferred to the telemetry unit and is scheduled for discharge the following morning.

• Brand Name: ALTO
• 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 ; 8009832284
• MDR Report Key: 24645817
• Report Number: 3008011247-2026-00016
• Device Sequence Number: 9786251
• Product Code: MIH
• UDI-Device Identifier: 00850007370916
• UDI-Public: (01)00850007370916(17)270208(10)FS020624-80
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 02/24/2026

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 Model Number: TV-AB3480-N
• Device Lot Number: FS020624-80
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2024
• 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 #FF102023-02; OVATION IX ILIAC LIMB, LOT #FS010324-60; OVATION IX ILIAC LIMB, LOT #FS031224-23; RIGHT RENAL CHIMNEY STENT (NON-ENDOLOGIX)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male