MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number	A34-34/C100-O20 V
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Aneurysm (1708); Clinical Endoleak (4843)
Date of Event	09/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in this event will not be returned for evaluation as it remains implanted in the patient.Patient medical records and imaging studies will be requested for further evaluation by the clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Device iteration is afx with duraply.
Event or Problem Description
The patient was treated for an abdominal aortic aneurysm (aaa) with the implant of an afx2 bifurcated stent graft, an afx vela suprarenal, and afx infrarenal on (b)(6) 2022.The routine follow-up computed tomography (ct) performed on (b)(6) 2023 found that the aneurysm sac remains the same size at 8.25cm.The angiograms from the index procedure were reviewed again and it was found that the proximal extension (afx vela suprarenal) had landed low to the renal.Though contrast was not seen on the recent ct, the physician suspects a type ia endoleak.Additionally, there is a possible type ib endoleak.Reportedly, pre-reintervention, the patient was doing fine and did not have any symptoms.Reintervention was completed on (b)(6) 2023.At reintervention, the type ia or type ib endoleaks were unable to be confirmed as the sac was filled with thrombus.The primary indicator of the possible endoleaks is that the aaa had grown slightly over the past two (2) years.It was also noted that the original proximal extension landed very low in the neck and did not have adequate seal length-only about 5mm of seal; therefore, an additional afx vela suprarenal was implanted.Though a type ib endoleak could not be confirmed, both the left and right common iliacs were extended with an ovation ix extender for durability.The patient is reported to be doing well post 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.Endologix was unable to perform an evaluation of the device as it remains implanted in the patient.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the aneurysm enlargement, type 1a and type 1b endoleak complaint is unconfirmed.The re-intervention procedure is confirmed.This is moderately consistent with the reported adverse event/incident.Device, user, procedure or anatomy relatedness of this complaint could not be determined.Procedure related harms for this complaint could not be determined.Although the clinical evaluation was unable to identify the contributing factors for the reported event.The physician mentioned short proximal neck and short distal seal zone at the biia (bilateral internal iliac artery).Additionally, there is reporting of any specific type of endoleak.The final patient status was reported to be stable.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.Corrections: g3: awareness date ¿ updated.H6: investigation finding codes - remove code 3233.H6: investigation conclusion codes - remove code 11.

• Brand Name: AFX
• Common Device Name: VELA SUPRARENAL
• 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: 18052180
• Report Number: 3011063223-2023-00027
• Device Sequence Number: 17657530
• Product Code: MIH
• UDI-Device Identifier: 00818009013651
• UDI-Public: (01)00818009013651(17)240212
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 10/12/2023

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 Expiration Date: 02/12/2024
• Device Model Number: A34-34/C100-O20 V
• Device Lot Number: 2425987008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/21/2023
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 01/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2021
• 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: AFX VELA INFRARENAL, LOT # 2410464003.; AFX2 BIFURCATED STENT GRAFT, LOT # 2419299002.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male