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

Model Number	TV-AB2380-N
Medical Device Problem Code	Device Stenosis (4066)
Health Effect - Clinical Codes	Pain (1994); Stenosis (2263)
Date of Event	02/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported adverse event/incident was investigated in alignment with 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 was unable to be performed by endologix as it remains implanted in the patient.A clinical evaluation of the adverse event/incident was completed via examination of medical records and/or medical imaging received by endologix and reported information by the distributor.Due to lack of comparative imaging, the stenosis (proximal portion of the left limb of the alto main body) and additional endovascular procedure complaints are unconfirmed.This is not consistent with the reported adverse event/incident.Device, user, procedure or anatomy relatedness of complaint cannot be determined.No procedure related harms were identified.However, it was reported that the left and right limbs were offset by approximately one marker, which could have predisposed the limb to narrowing and subsequent stenosis; however, this could not be conclusively determined.The p2+40 diameter at the proximal margin of the iliac limbs was 21.5mm.Each polymer-filled iliac limb measures approximately 14mm in diameter, resulting in two limbs competing for limited space.This space constraint could have contributed to limb stenosis but could not conclusively be determined.There was off label concomitant product use involving a proximal non-endologix cuff.It is unclear whether this contributed to the reported event.The stenosis was reportedly treated with deployment of a bare metal stent (non-endologix), and the procedure was completed.The final patient status was not reported.No additional investigation of this reported adverse event/incident is planned.However, should additional information relevant to the investigation¿s 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 treated for abdominal aortic aneurysm on (b)(6) 2026.The inferior mesenteric artery and the lumbar artery were embolized with coils.A gore (non-endologix) 26x33 cuff was deployed to embolize the proximal lumbar artery.The alto main body was deployed via right access.Contralateral cannulation was completed within 7 minutes of deployment.The contralateral ovation ix iliac limb was deployed.Balloon touch up was performed at fourteen minutes on the proximal portion of the alto main body, followed by the deployment of the ipsilateral ovation ix iliac limb.After ballooning the junctions between the limbs and the alto main body, the procedure was completed with no endoleaks.Following discharge, on (b)(6) 2026, the patient complained of left leg pain.Examination revealed stenosis in the proximal portion of the left leg of the alto main body.The stenosis was treated with deployment of a bare metal stent (non-endologix), and the procedure was completed.It was noted that the positioning height of the left and right limbs differed by approximately one marker.The stenosis was likely to have occurred because the anatomy at ir+40 being relatively narrow and there was insufficient radial force without a stent.

• 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: 24715120
• Report Number: 3008011247-2026-00017
• Device Sequence Number: 14888030
• Product Code: MIH
• UDI-Device Identifier: 00850007370886
• UDI-Public: (01)00850007370886(17)280207(10)FS020425-04
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 03/02/2026

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 Model Number: TV-AB2380-N
• Device Lot Number: FS020425-04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2025
• 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: COILS (NON-ENDOLOGIX) (LN UNK).; CUSTOM SEAL KIT FILL POLYMER (LN FF022425-01).; GORE (NON-ENDOLOGIX) CUFF 26X33 (LN UK).; OVATION IX ILIAC LIMB (LN FS042624-30).; OVATION IX ILIAC LIMB (LN FS102224-30).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male