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

Model Number	TV-AB2980-N
Medical Device Problem Codes	Off-Label Use (1494); Lack of Effect (4065)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	06/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in this event will not be returned for evaluation as it remains implanted in the patient.Patient medical records and imaging studies will be requested for further evaluation by the clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
The patient was implanted with the alto stent graft system to treat an abdominal aortic aneurysm (aaa).During this initial procedure after deploying the ovation ix limbs and ballooning there was a large type ia endoleak even after multiple balloon inflations.The physician elected to add a palmaz stent (non-endologix) then ballooned.The endoleak was still present so a high-pressure balloon was used and inflated.The type ia endoleak was greatly diminished but not eliminated.The physician believes it will go away when the patient is off anticoagulation.The patient was transferred to the post-anesthesia care unit stable and will be followed by computed tomography evaluation.
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.An evaluation of the device could not be completed.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 that the type 1a endoleak complaint is confirmed.This is consistent with the reported adverse event/incident.The complaint is likely user related due to the off-label use of the presence of significant calcification within the proximal sealing zone.Significant calcification was present at the level of p2+7 mm below the inferior renal artery within the proximal sealing zone, likely resulting in suboptimal graft apposition which contributed to the reported type ia endoleak.No procedure related harms were identified.The final patient status was reported as discharged home on postoperative day three in stable condition 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: b5: describe event or problem ¿ additional information.G3: date received by manufacturer has been updated.H6: result code: remove code 3233.H6: conclusion code: remove code 11.
Event or Problem Description
Confirmation was received on 03 september 2025, that the follow-up computed tomography has not yet been performed.

• 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: 22456784
• Report Number: 3008011247-2025-00057
• Device Sequence Number: 18292160
• Product Code: MIH
• UDI-Device Identifier: 00850007370909
• UDI-Public: (01)00850007370909(17)270629(10)FS032724-32
• 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: 2025
• 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): 06/10/2025

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-AB2980-N
• Device Lot Number: FS032724-32
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2024
• 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, LOT # FF120524-02.; OVATION IX ILIAC LIMB, LOT # FS040723-12.; OVATION IX ILIAC LIMB, LOT # FS050725-32.; PALMAZ STENT (NON-ENDOLOGIX).
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female