MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA INFRARENAL

Model Number	A25-25/C75V
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Ischemia (1942); Renal Failure (2041); Ruptured Aneurysm (4436)
Date of Event	09/11/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
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.Device iteration is afx with duraply.H3 other text : the device was not returned.
Event or Problem Description
The patient was being treated for an abdominal aortic aneurysm on (b)(6) 2024.The procedure was reportedly off-label due to the patient having a challenging calcified anatomy.The afx vela infrarenal was implanted and during ballooning with a (non-endologix) medtronic reliant balloon, the patient's abdominal aorta ruptured at the level of the renal arteries.This prompted the physician to quickly convert to an open surgical repair and the afx vela infrarenal was explanted.It was later reported that the patient passed away on (b)(6) 2024 due to complications from the aortobifemoral 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 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 to have been 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 ruptured aorta (intraoperative), surgical conversion with explant and death complaints are confirmed.This is consistent with the reported adverse event/incident.The complaint is most likely user and anatomy related due to the patient being treated for revascularization of aortoiliac occlusive disease and there was no abdominal aortic aneurysm.This off label usage likely contributed to the reported events.Additionally, the right common iliac distal diameter was 5.2mm and the left common iliac diameter was 6.4mm and these should be 10-23mm.The neck diameter at p2 was 13.8mm and should be 18-32mm.There calcium chunks in bifurcation and iliacs were nearly occlusive which is cautionary product use.The procedure related harms identified are prolonged procedure, abnormal blood loss, hemodynamic instability with hemorrhagic shock, acute kidney injury, mesenteric ischemia, and additional surgical procedure.The final patient status was reported as deceased on postoperative day two.The patient death was determined to.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.Device iteration is afx with duraply.G3: awareness date ¿ updated.H3: device evaluated by manufacturer ¿ updated.H6: investigation finding codes - remove code 3233.H6: investigation conclusion codes - remove code 11.

• Brand Name: AFX
• Common Device Name: VELA INFRARENAL
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer (Section G): ENDOLOGIX; 2 musick; ,; irvine CA 92618
• Manufacturer Contact: gary kirchgater ; 2 musick; ,; irvine, CA 92618 ; 8009832284
• MDR Report Key: 20358148
• Report Number: 3011063223-2024-00143
• Device Sequence Number: 20635124
• Product Code: MIH
• UDI-Device Identifier: 00818009013491
• UDI-Public: (01)00818009013491(17)270619
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted 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): 09/11/2024

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: A25-25/C75V
• Device Lot Number: 2820280-004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/11/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2024
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 74 YR
• Patient Sex: Female