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

Model Number	TV-AB2980-N
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	11/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in this event will not be returned for evaluation as it remains implanted in the patient.Patient medical records are not available.Imaging studies have been received for further evaluation by the clinical specialist.A follow-up report will be submitted upon completion of clinical analysis.
Event or Problem Description
The patient was being implanted with the alto stent graft system to treat an abdominal aortic aneurysm (aaa) on (b)(6) 2025.The aortic neck diameter below the renal arteries was 20.6mm and 7mm distally the diameter was 23.1mm.A (non-endologix) stent was placed in the left renal artery for expansion.The inferior mesenteric artery (ima) and the lumbar artery were also embolized by placing a 36×4.5 gore (non-endologix) excluder.The alto main body was deployed to align with the inferior edge of the lowest renal artery.During polymer filling, distal migration of the main body by approximately 3mm was confirmed.After 14 minutes, the integrated balloon was used for dilation.Contralateral leg cannulation was performed using the crossover lumen.At this time, further distal migration of the main body by approximately 2mm was observed and an angiogram confirmed a type 1a endoleak.After the right and left iliac limbs were implanted balloon touch-up on the sealing ring was performed and a subsequent angiogram still confirmed the type 1a endoleak.The following devices were additionally deployed at the sealing ring, 32×4.5, 28.5×3.3, 36×4.5 gore (non-endologix) excluders.Additionally, the following non-endologix devices were placed at the leak site of the sealing ring rubycoil 3.0×15cm, packingcoil 60cm ×2, packingcoil 30cm ×1, packingcoil 5cm ×12 and three embold 4×15cm.The final angiogram confirmed no endoleaks and the procedure was completed.
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.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 malposition of the device is unconfirmed.The type 1a endoleak (resolved) and addition endovascular procedure are confirmed.This is moderately consistent with the reported adverse event/incident.The type 1a endoleak was identified intraoperatively and subsequently reported as resolved following an additional intervention.This was confirmed upon review of the imaging provided.Device, user, procedure or anatomy relatedness of this complaint could not be determined.Procedure related harms could not be determined.It was reported that the procedure was completed without evidence of an endoleak; however, the final patient status was not reported.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.Corrections: b6: relevant tests and lab data has been updated.G3: awareness date has been updated.H6: investigation finding codes: remove code 3233.H6: investigation conclusion codes: remove code 11.

• 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: 23816611
• Report Number: 3008011247-2025-00106
• Device Sequence Number: 21157082
• Product Code: MIH
• UDI-Device Identifier: 00850007370909
• UDI-Public: (01)00850007370909(17)280729(10)FS072325-27
• 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: 2025
• 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
• Report Date (Section B): 12/04/2025

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 Model Number: TV-AB2980-N
• Device Lot Number: FS072325-27
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2025
• 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: CUSTOMSEAL KIT FILL POLYMER, LOT # FF072924-01.; GORE EXCLUDER 28.5×3.3 (NON-ENDOLOGIX).; GORE EXCLUDER 32×4.5 (NON-ENDOLOGIX).; GORE EXCLUDER 36×4.5 (NON-ENDOLOGIX).; OVATION IX ILIAC LIMB, LOT # FS081425-24.; OVATION IX ILIAC LIMB, LOT # FS092324-01.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown