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

Model Number	TV-AB2080-N
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Codes	Aneurysm (1708); Clinical Endoleak (4843)
Date of Event	05/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was treated for the abdominal aortic aneurysm on (b)(6) 2024 with the implant of an alto abdominal aortic stent graft system.A routine follow-up diagnostic angiogram performed on (b)(6) 2025, identified aneurysm enlargement and a possible type ia endoleak.Reportedly, the physician plans to schedule an intervention to implant a palmaz (non-endologix) stent.The patient is stable.
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation and remain implanted in the patient.Patient medical records have been received and imaging studies have been requested 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
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 could not perform an evaluation of the device as the device remains implanted in the patient.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the aneurysm enlargement complaint is unconfirmed.The type ia endoleak and additional endovascular procedure (diagnostic angiogram) complaints are confirmed.This is moderately consistent with the reported adverse event/incident.The clinical assessment determined that a type ii endoleak of the lumbar arteries occurred that was not included in the event as reported.This was discovered during review of the computed tomography scans dated (b)(6)l 2025.The presence of severe calcification in the aortic neck likely resulted in inadequate stent graft apposition, leading to a type ia.The type ii endoleak of the lumbar artery is anatomy related.No procedure related harms were identified.The final patient status is reported as being stable.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 - updated.G3: awareness date - 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: 22062594
• Report Number: 3008011247-2025-00041
• Device Sequence Number: 7639489
• Product Code: MIH
• UDI-Device Identifier: 00850007370381
• UDI-Public: (01)00850007370381(17)270502(10)FS042924-67
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2025

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-AB2080-N
• Device Lot Number: FS042924-67
• 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: 05/01/2025
• Supplement Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/31/2024
• 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 (LN FF042324-02); OVATION IX ILIAC LIMB (LN FS012624-47); OVATION IX ILIAC LIMB (LN FS040324-25)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 82 YR
• Patient Sex: Female