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

Model Number	TV-AB2380-N
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	02/26/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported adverse event/incident was investigated in alignment with 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.An evaluation of the device was unable to be performed by endologix as it remains implanted in the patient.A clinical evaluation of the adverse event/incident was completed via examination of medical records and/or medical imaging received by endologix and reported information by the distributor.The malposition of the device (sealing ring positioned over the right renal artery) causing right renal artery occlusion complaint is confirmed.This is consistent with the reported adverse event/incident.Device, user, procedure or anatomy relatedness of the malposition cannot be determined.Procedure related harms are right renal artery occlusion.The procedure was reported as completed, and no further intervention is planned at this time.The patient¿s final status was not reported.No additional investigation of this reported adverse event/incident is planned.However, should additional information relevant to the investigation¿s outcome become available, a follow-up report will be submitted.Endologix will continue to monitor this and similar adverse events/incidents.H3 other text: device remains implanted in patient.
Event or Problem Description
The patient was treated for an abdominal aortic aneurysm on (b)(6) 2026 with the implant of an alto abdominal stent graft system which resulted in untreated right renal occlusion.The alto main body delivery system was inserted via a right approach.The renal arteries were contrast-imaged to identify their approximate locations.After the mid-crown of the alto main body was deployed, balloon expansion was performed.Following parallax adjustment, renal artery angiography was performed again.After injecting the polymer fill and confirming that the sealing ring position was appropriate, the proximal crown was deployed.Contralateral cannulation was performed using the crossover lumen.Fourteen minutes later, balloon expansion was carried out for two minutes.At this point, it was observed that the alto main body sealing ring was slightly overlapping the right renal artery, and the blood flow in the right renal artery was delayed; therefore, corrective action was taken.A sheath was inserted via the left arm, and an attempt was made to cannulate the renal artery, but it was unsuccessful.Follow-up angiography revealed that the renal artery was completely occluded.When cannulation was attempted from the limb, the microwire entered the renal artery, but the stent (express) balloon could not be inserted.Therefore, it was decided to prioritize the completion of both limb placements.The bilateral ovation ix iliac limbs were deployed, followed by deployment of an excluder (non-endologix) leg.Post-touch-up angiography confirmed the absence of endoleaks.An attempt to cannulate the renal artery was made again but was unsuccessful, and the procedure was concluded.Currently, there are no plans for additional intervention for the patient.

• 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: 24744067
• Report Number: 3008011247-2026-00020
• Device Sequence Number: 15760506
• Product Code: MIH
• UDI-Device Identifier: 00850007370886
• UDI-Public: (01)00850007370886(17)280213(10)FS020525-09
• 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: 2026
• 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
• Report Date (Section B): 03/05/2026

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-AB2380-N
• Device Lot Number: FS020525-09
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2025
• 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: FILL POLYMER CUSTOM SEAL KIT (LN FF052725-01).; GORE (NON-ENDOLOGIX) EXCLUDER LEG (LN UNK).; OVATION IX ILIAC LIMB (LN FS04032516).; OVATION IX ILIAC LIMB (LN FS04102515).
• Outcome Attributed to Adverse Event: Disability
• Patient Sex: Male