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

Model Number	TV-AB2980-N
Medical Device Problem Code	Filling Problem (1233)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	07/25/2024
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.Where possible, it is endologix's practice to make at least three good faith efforts to retrieve a reported adverse event/incident-related device, as well as relevant 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 confirmed that the device was properly manufactured and released in accordance with the device master record.The review confirms that no manufacturing or processing non-conformities were identified that would have contributed to the reported adverse event/incident.A clinical evaluation of the adverse event/incident could not be completed.No medical records or medical imaging relevant to the reported adverse event/incident were received by endologix.The user facility was unable to provide this information.As such, event determination, off-label conditions, related patient harms, and patient disposition could not be independently assessed.No contributing factors were identified.Due to the absence of medical records and medical imaging, the relationship of the device, use, procedure, and/or anatomy to this adverse event/incident could not be evaluated.The final patient status remains unknown and was not made available to endologix.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.H3 other text : device remains implanted.
Event or Problem Description
The patient was being treated for an abdominal aortic aneurysm (aaa) with the implant of the alto abdominal stent graft system on (b)(6) 2024.During the procedure, issues arose with the polymer injection using the auto-injector.Initially, only the ipsilateral limb rings were filled.Attempts to resolve this by exchanging the auto-injector and adjusting the device position failed.About five (5) minutes after the initial polymer injection, the physician manually pushed the syringe with significant force, slightly filling the sealing ring, but the polymer started to cure.Further attempts to push the syringe manually were unsuccessful as the polymer had already cured inside.A second polymer from the same lot was used, but the already cured polymer inside the delivery system blocked the new injection.The second polymer was also cured, within five (5) minutes.A balloon touch-up was performed fourteen (14) minutes after the first injection.Angiography revealed a type ia endoleak.The contralateral gate was accessed through the cross-over lumen, and both contralateral and ipsilateral limbs were implanted.A (non-endologix) excluder cuff was implanted proximally.A type ii endoleak (non-device related) was observed after the procedure.

• 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: 20032724
• Report Number: 3008011247-2024-00092
• Device Sequence Number: 12389173
• Product Code: MIH
• UDI-Device Identifier: 00850007370909
• UDI-Public: (01)00850007370909(17)261019(10)FS101723-21
• 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: 2024
• 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): 07/29/2024

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: FS101723-21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2023
• 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: NON-ENDOLOGIX EXCLUDER CUFF.; OVATION IX ILIAC LIMB LOT# FS010323-27.; OVATION IX ILIAC LIMB LOT# FS110823-10.; OVATION PRIME FILL POLYMER LOT# FF082223-01.; OVATION PRIME FILL POLYMER LOT# FF082223-01.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR
• Patient Sex: Male