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

Model Number	TV-AB2080-N
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Integrity Problem (2978)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	04/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was being treated for an abdominal aortic aneurysm (aaa) on (b)(6) 2026 with the implant of an alto abdominal stent graft system.It was reported that the during the procedure a polymer leak was suspected.Following the deployment of the alto bifurcated stent graft via a right approach per the standard procedure, the polymer kit was connected, and polymer injection was performed.Polymer was injected into all rings; the ipsilateral ring, sealing ring, support ring, contralateral ring, and the procedure moved to contralateral cannulation.During the procedure, it was confirmed that the fill syringe connected to the fill connector bottomed out although polymer should have remained in it.Suspecting a polymer leak, the physician clamped the fill connector tube with forceps.Simultaneously, the patient¿s blood pressure dropped acutely to the 50s.The anesthesiologist administered norepinephrine, and although it took some time, the blood pressure recovered to the 100s.The procedure was continued, and after 14 minutes, touch-up was performed using the integrated balloon.The contralateral limb and the ipsilateral limb were deployed, then touch-ups were performed at the junctions and distal ends.Final angiography confirmed no endoleak.The physician confirmed peripheral hemodynamics with palpable pulses, and the procedure was concluded.The final patient status was not reported.Computed tomography images reviewed by the distributors clinical team reportedly identified contrast findings near the sealing ring.Apparently, it is unclear whether this contrast enhancement is due to pre-existing calcification or is indicative of a polymer leak or possibly a leak from the graft itself.
Additional Manufacturer Narrative
The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.Medical records were denied by the distributor; however, medical imaging was received.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.A clinical evaluation of the adverse event/incident was completed.An examination of medical imaging received by endologix found the possible indeterminate endoleak is refuted.The intraoperative hypotension and polymer leak complaints are unconfirmed.This is not consistent with the reported adverse event/incident.The reported suspected polymer leak (fill syringe prematurely bottomed out) with concurrent acute hypotension (sbp 50s) requiring norepinephrine could not be confirmed due to lack of medical records.The reported intraoperative hypotension was resolved with medical management, and its cause remains unclear.It was reported that the aortic and iliac rings were successfully polymer-filled, resulting in an adequate proximal seal with no endoleak on completion angiography.There was pre-existing calcific plaque at the proximal neck that was also visualized postoperatively at the sealing ring.No endoleak was identified.Device, user, procedure or anatomy relatedness of this complaint could not be determined.Procedure related harms could not be determined.The final patient status remains unknown as it was not made available to endologix.

• 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: 25125946
• Report Number: 3008011247-2026-00038
• Device Sequence Number: 18815180
• Product Code: MIH
• UDI-Device Identifier: 00850007370381
• UDI-Public: (01)00850007370381(17)270329(10)FS032724-15
• 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,Followup
• Report Date (Section B): 04/10/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: TV-AB2080-N
• Device Lot Number: FS032724-15
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/10/2026
• Supplement Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 05/08/2026
• Supplement Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2024
• 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 (LOT# FF060225-01); OVATION IX ILIAC LIMB (LOT# FS071425-45); OVATION IX ILIAC LIMB (LOT# FS090225-18)
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 79 YR
• Patient Sex: Female