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

Model Number	TV-AB2680-N
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	07/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was treated for an abdominal aortic aneurysm with the implant of the alto abdominal graft system on (b)(6) 2024.Reportedly, calcification was observed around the renal arteries, and the neck angle was 45 degrees.After embolizing the lumbar artery, the alto main body was deployed; positioned slightly more proximal than planned.Balloon touch-up was performed at 14 minutes post polymer fill.Angiography showed the sealing ring was floating, but the support rings were apposed to the vessel, confirming that there were no endoleaks.The bilateral limbs were deployed, and the procedure was completed.On (b)(6) 2025, a type ia endoleak was confirmed.Reintervention is planned to add a cuff and coils; however, the date has not yet been provided.
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation as they remain implanted in the patient.Patient medical records and imaging studies are being requested by the distributor for further evaluation by a clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Additional Manufacturer Narrative
The reported 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.Endologix was unable to perform an evaluation of the device remains implanted in the patient.A clinical evaluation of the adverse event/incident could not be completed.No medical records nor medical imaging relevant to the reported adverse event/incident was received by endologix.Due to the lack of receipt of relevant medical records and/or imaging; event determination, off label conditions, related patient harms and patient disposition could not be independently assessed.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 incidents.Corrections: h6: investigation type codes ¿ remove 4118.H6: investigation finding codes - remove code 3233.H6: investigation conclusion codes - remove code 11.
Additional Manufacturer Narrative
Corrections: b2: outcomes attributed to ae ¿ updated.B5: describe event or problem ¿ additional.G3: awareness date ¿ updated.H6: health effect - impact code ¿ remove 4614.
Event or Problem Description
The patient was treated for an abdominal aortic aneurysm with the implant of the alto abdominal graft system on (b)(6) 2024.Reportedly, calcification was observed around the renal arteries, and the neck angle was 45 degrees.After embolizing the lumbar artery, the alto main body was deployed; positioned slightly more proximal than planned.Balloon touch-up was performed at 14 minutes post polymer fill.Angiography showed the sealing ring was floating, but the support rings were apposed to the vessel, confirming that there were no endoleaks.The bilateral limbs were deployed, and the procedure was completed.On (b)(6) 2025, a type ia endoleak was confirmed.Reintervention is planned to add a cuff and coils; however, the date has not yet been provided.Reintervention was performed on (b)(6) 2025.After coil embolization a gore (non-endologix) cuff was implanted.A vbx stent was also implanted in the left renal artery.The final patient status was not provided.

• 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: 22817587
• Report Number: 3008011247-2025-00070
• Device Sequence Number: 13015332
• Product Code: MIH
• UDI-Device Identifier: 00850007370893
• UDI-Public: (01)00850007370893(17)260110(10)FS010523-27
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/07/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/10/2026
• Device Model Number: TV-AB2680-N
• Device Lot Number: FS010523-27
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2025
• Supplement Date Received by Manufacturer: Not provided; 09/23/2025
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 08/22/2025; 09/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2023
• 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 (LN FF051823-01).; OVATION IX ILIAC LIMB (LN FS042523-19).; OVATION IX ILIAC LIMB (LN FS120622-41).
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown