MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number	A34-34/C100-O20V
Medical Device Problem Codes	Off-Label Use (1494); Lack of Effect (4065)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	10/03/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was being treated for an endovascular repair (evar) of a fusiform aortic aneurysm with the implant of an afx2 bifurcated stent graft (bsg) and afx vela suprarenal on (b)(6) 2019.Reportedly, the patient had a relatively thick and calcified proximal neck.Due to the relatively short right common iliac artery, coil embolization was performed, and then a gore (non-endologix) excluder cuff was implanted.This initial procedure is outside the indications of use (off-label) due to the use of adjunctive devices not compatible with afx2 system per the ifu.The afx2 bsg was inserted to gently sit on the aortic bifurcation through the right femoral approach before an afx vela suprarenal was added.After balloon touch-up was performed lightly, angiography showed an endoleak that appeared to be type ia or type iiia.Another afx vela infrarenal was implanted immediately below the renal arteries.After touch-up was performed, the final angiography showed that the endoleak became less noticeable.It was determined that the patient would be discharged and monitored through follow-up appointments.
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation and remain implanted in the patient.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, follow-up report will be submitted.Device iteration is afx with duraply.
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.There are no other equivalent adverse events/incidents for this lot number existing within the endologix complaint handling system.An evaluation of the device could not be completed.The device was not returned to endologix for evaluation because it remains implanted.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix found the type ia endoleak, type iiia endoleak and additional endovascular procedure complaints are unconfirmed.This is not consistent with the reported adverse event/incident.Device, user, procedure or anatomy relatedness of this complaint cannot be determined.Procedure related harms could not be identified.During the investigation, endologix found reasonable evidence to suggest the device was used off-label.The procedure is outside the indications of use (off-label) due to the use of adjunctive devices (gore excluder cuff) not compatible with afx system per the ifu.The final patient status was reported as discharged and being monitored.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: 21453918
• Report Number: 3011063223-2025-00019
• Device Sequence Number: 7158493
• Product Code: MIH
• UDI-Device Identifier: 00818009013606
• UDI-Public: (01)00818009013606(17)211025
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Recall,Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2025

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: 10/25/2021
• Device Model Number: A34-34/C100-O20V
• Device Lot Number: 2004753005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2025
• Supplement Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2018
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0008-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX (TREATMENT) VELA INFRARENAL (LOT# 2243604001); AFX2 BIFURCATED STENT GRAFT (LOT# 2254826009); GORE (NON-ENDOLOGIX) EXCLUDER CUFF 1 (LOT# UNK); UNK (NON-ENDOLOGIX) COILS (LOT# UNK)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown