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

Model Number	TV-AB2080-N
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	05/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.Endologix did not make any attempts to retrieve the reported adverse event/incident-related device nor medical records, nor medical imaging because the distributor stated they were unable to obtain any of this information therefore, it could not be made available for investigation.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.There are no other equivalent adverse events/incidents for this lot number existing within the endologix complaint handling system.An evaluation of the device could not be completed because the device was not returned to endologix for evaluation.The distributor stated it was not available for investigation.A clinical evaluation of the adverse event/incident could not be completed.No medical records nor medical imaging relevant to the reported adverse event/incident was received by endologix.The distributor was unable to provide this information.Due to the absence of medical records and medical imaging device, use, procedure, and/or anatomy relatedness to this incident could not be evaluated.As such, event determination, off label conditions, related patient harms and patient disposition could not be independently assessed.The patient is currently still hospitalized and being monitored.No additional investigation of this reported incident is planned.This and similar incident will continue to be monitored.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.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) on (b)(6) 2025 with the implant of an alto abdominal stent graft system.The main body was placed without any issues, and polymer filling was completed.Subsequently, the contralateral limb and the ipsilateral limb were also implanted.Angiography confirmed no endoleaks, and the procedure was completed.On (b)(6) 2025 it was decided that the stent graft would be removed due to infection.Although the aaa decreased in size after alto implantation, an infection was confirmed due to raoultella spp.The patient's symptoms due to the infection are unknown.The explant procedure was performed on (b)(6) 2025, and the bare portion of the alto was cut.The entire graft was removed and replaced with a y-shaped artificial blood vessel.The patient is currently still hospitalized and being monitored.

• 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: 22345357
• Report Number: 3008011247-2025-00051
• Device Sequence Number: 17336380
• Product Code: MIH
• UDI-Device Identifier: 00850007370381
• UDI-Public: (01)00850007370381(17)260714(10)FS071223-33
• Combination Product (Y/N): N
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted 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
• Report Date (Section B): 06/09/2025

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: 07/14/2026
• Device Model Number: TV-AB2080-N
• Device Lot Number: FS071223-33
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2023
• 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: CUSTOMSEALKIT POLYMER FILL (LOT# FF031924-01).; OVATION IX ILIAC STENT GRAFT (LOT# FS030124-45).; OVATION IX ILIAC STENT GRAFT (LOT# FS041724-60).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown