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

Model Number	TV-AB3480-N
Medical Device Problem Codes	Malposition of Device (2616); Lack of Effect (4065)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	01/21/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The explanted graft involved in this event will not be returned for evaluation as it was discarded.Though patient medical records and imaging studies were received for the previously reported event, current medical records and imaging studies will be requested for further evaluation by the clinical specialist.A follow-up report will be submitted upon completion of the clinical evaluation.
Event or Problem Description
The patient was implanted with the alto stent graft system to treat an abdominal aortic aneurysm (aaa).After the stent-graft was deployed, a type 1a endoleak was identified.The physician felt there were very limited options for repairing intraoperatively type 1a endoleak due to length from renal to top of limbs being less than 45mm, and physician did not want to palmaz due to other surgical and endo options.The patient is being monitored.Additional information: it was reported that the intraoperative type ia endoleak has not been resolved and it is unknown if further intervention will be performed.The patient is currently doing fine.This event was previously reported under mdr # 3008011247-2021-00081.Additional information: it was reported that currently the stent graft was found to have settled into the reverse taper neck coming down lower than intended and the stent graft radio opaque markers are sitting 5-7mm below the renal with the center of the ring sitting at 15mm below the renal where the neck is 39mm in diameter.The endoleak appears to be all anterior on centerline.It was noted that coiling around the ring could be attempted if an open repair is not a feasible option.Implant of an aortic cuff would not be a good fit based on the short 34mm distance from the renal to top of the limbs and due to the reverse taper diameters of the aorta in this area.The physician elected to explant the stent graft on (b)(6) 2026 and the patient was reported as doing well post operatively.The explanted stent graft is not available for return.
Additional Manufacturer Narrative
The reported incident was investigated in alignment with endologix operating procedures and work instructions.Where possible, it is endologix practice to make at least three good faith efforts to retrieve a reported adverse event/incident related device.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.The explanted stent graft was not returned to endologix and it was discarded.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 type 1a endoleak (loss of seal) and surgical explant are confirmed.This is consistent with the reported adverse event/incident.The complaint is likely anatomy related.The 7 mm reversed taper of the aortic neck likely contributed to intraoperative movement of the aortic body during the index procedure, resulting in the device landing lower than intended.This malposition of the sealing ring likely compromised the proximal seal zone and contributed to the recurrent type 1a endoleak.No procedure related harms were identified.The final patient status was reported as discharged to home on postoperative day five in stable condition.The clinical assessment determined that there was evidence to reasonably suggest an additional surgical procedure (aneurysm plicated to treat a type 1a endoleak) was performed on an unknown date that was not included in the event as reported.The additional surgical procedure was discovered during review of the discharge summary dated january 26, 2026.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: medical device problem codes: remove code 4065.H6: investigation type codes: remove code 4118.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: 24308889
• Report Number: 3008011247-2026-00003
• Device Sequence Number: 15872918
• Product Code: MIH
• UDI-Device Identifier: 00850007370916
• UDI-Public: (01)00850007370916(17)240319(10)FS03172113
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted 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,Followup
• Report Date (Section B): 01/22/2026

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 Expiration Date: 03/19/2024
• Device Model Number: TV-AB3480-N
• Device Lot Number: FS031721-13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2026
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2021
• 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 # FF012021-01; OVATION IX ILIAC LIMB, LOT # FS041421-06; OVATION IX ILIAC LIMB, LOT # FS042221-33
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male