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

Model Number	TV-AB2980-N
Medical Device Problem Codes	Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	02/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with an alto stent graft system on (b)(6) 2022.The alto main body was used as an aorto-uni-iliac (aui) device, securing the contralateral limb with sutures after failing to cross the right common iliac artery.Approximately two (2) years post index procedure follow-up identified a type ib endoleak.The type ib endoleak originated from the tied-off limb.Reintervention was performed on (b)(6) 2025.A tapered afx limb stent graft was implanted to seal the affected limb and extended proximally using an ovation ix extender.The type ib endoleak was successfully resolved.The patient was discharged.
Additional Manufacturer Narrative
The reported adverse event/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 as well as medical records and medical imaging.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 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 the type ib endoleak of the right common iliac artery and an additional endovascular procedure is confirmed.This is consistent with the reported adverse event/incident.The complaint is likely anatomy and user-related.At the index procedure, the alto graft was used as an auto-uni-iliac (aui) device due to the inability to cross the right common iliac artery due to preexisting occlusion (off-label use).There was also a preexisting subtotal occlusion of the right common iliac artery (anatomy-related).No procedure-related harms were identified.The final patient status was reported as discharged to home in stable condition on postoperative day two.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.This adverse event/incident was previously submitted to the fda on 25 march 2025 under the incorrect fe # 3011063223.Please reference 3011063223-2025-00027 for the initial reporting of this adverse event/incident.

• 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: 22063072
• Report Number: 3008011247-2025-00043
• Device Sequence Number: 12725189
• Product Code: MIH
• UDI-Device Identifier: 00850007370909
• UDI-Public: (01)00850007370909(17)250712(10)FS061322-55
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/24/2025

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 Expiration Date: 07/12/2025
• Device Model Number: TV-AB2980-N
• Device Lot Number: FS061322-55
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2022
• 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# FF030922-02; OVATION IX ILIAC LIMB LOT# FS060322-22
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male