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

Model Number	TV-AB2680-N
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	05/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation.Patient medical records and imaging studies will be requested for further evaluation by a 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 treated for an abdominal aortic aneurysm (aaa) on (b)(6) 2024, with the implantation of the alto abdominal aortic aneurysm stent system.During the procedure, the physician encountered difficulties in delivering the device.It was reported that the pressure from the advanced device caused an iliac artery rupture.The rupture was subsequently stented and repaired using a gore viabahn (non-endologix) stent.The aaa was successfully treated, and the patient was reported to be in stable condition following the procedure.
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 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 shows the device was properly manufactured and released in accordance with the device master record.The review confirms there were no manufacturing or processing non-conformities identified that would contribute to the reported adverse event/incident.The device was not returned to endologix for evaluation.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the difficulty in advancing the delivery system, which is confirmed.The ruptured right external iliac artery complaint is also confirmed.This is consistent with the reported adverse event/incident.The complaints are most likely user-related (off-label).The procedure-related harm was an enterectomy of the right superficial artery due to a dissection flap in the proximal segment of the artery.The initial attempt at the evar procedure on may 17, 2024, was aborted due to the rupture of the right external iliac artery.The rupture was likely due to the difficulty in advancing the delivery system.The difficulty in advancing the delivery system was likely due to the off-label diameters of the right common iliac, right external iliac, and right superficial femoral artery, as well as the extensive tortuosity and calcification of the artery.The dissection flap in the right superficial femoral artery was likely caused by the off-label nature of the artery.The evar procedure was reattempted on (b)(6) 2024 and was successful.The final patient status was discharged on post-operative day seven (7) home 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: g3: awareness date ¿ updated.H6: investigation finding codes - remove code 3233.H6: investigation conclusion codes - remove code 11.

• Brand Name: ALTO
• Common Device Name: MAIN BODY DELIVERY SYSTEM
• 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: 19489853
• Report Number: 3008011247-2024-00069
• Device Sequence Number: 18278998
• Product Code: MIH
• UDI-Device Identifier: 00850007370893
• UDI-Public: (01)00850007370893(17)270116(10)FS011024-60
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2024

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-AB2680-N
• Device Lot Number: FS011024-60
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2024
• Supplement Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2024
• 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: OVATION PRIME FILL POLYMER LOT #FF082923-03.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR
• Patient Sex: Female