MAUDE Adverse Event Report: Endologix Santa Rosa Alto; Main Body

Model Number	TV-AB3480-N
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	07/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was implanted with the alto abdominal stent graft system to treat an abdominal aortic aneurysm (aaa) on (b)(6) 2026.During this initial procedure, a type ia endoleak was identified and treated with a palmaz stent (non-endologix).It was reported that the case was borderline on-label, the patient was not an open surgical candidate, and had no other treatment options.The patient was reported as doing fine, was expected to be discharged one day post-op, and scheduled for a 30-day follow-up.After the initial report, clinical assessment determined that the type ia endoleak was not resolved by the palmaz stent; however, it is unknown if the 30-day follow-up was performed to determine if the endoleak ultimately resolved.
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.Endologix was unable to perform an evaluation of the device as it remains implanted in the patient.A clinical evaluation of the adverse event/incident was completed.An examination of the medical imaging received by endologix shows that the type ia endoleak and additional palmaz stent is confirmed.However, the type ia endoleak was found to be persistent in nature.This is moderately consistent with the reported adverse event/incident.The complaint is most likely user related due to the off-label neck anatomy.The diameter in the area of the proximal sealing rings was off label, measuring 33.4mm where 30mm or less is indicated.A 34mm aortic body was sized to treat diameters of 27-30mm, which likely contributed to the type ia endoleak.Procedure related harms for this complaint could not be determined.The final patient status was reported as fine, with discharge on postoperative day one and plans to monitor in 30 days.Patient medical records and imaging studies have been requested for further evaluation by the clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted upon completing of clinical evaluation.

• 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 ; +1(800)983-2284
• MDR Report Key: 50897181
• Report Number: 3008011247-2026-00103
• Device Sequence Number: 5828879
• Product Code: MIH
• UDI-Device Identifier: 00850007370916
• UDI-Public: (01)00850007370916(17)290217(10)FS021026-24
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/07/2026

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: FS021026-24
• 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: 09/01/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2026
• 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 #FF030426-01; Ovation IX Iliac Limb, Lot #FS031926-31; Ovation IX Iliac Limb, Lot #FS042226-05; Palmaz Stent (Non-Endologix)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 82 YR
• Patient Sex: Female