MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number	A25-25/C95-O20 V
Medical Device Problem Codes	Appropriate Device Problem Term/Code Not Available (3191); Lack of Effect (4065)
Health Effect - Clinical Codes	Failure of Implant (1924); Clinical Endoleak (4843)
Date of Event	10/13/2022
Type of Reportable Event	Serious Injury
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, a follow-up report will be submitted.Device iteration is afx with duraply.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of an afx2 bifurcated stent graft and an afx vela suprarenal proximal extension.Approximately two and a half (2.5) years post initial procedure in summer 2022, the patient fell down and suffered a hematoma in the femoral area.Patient started feeling beats in the stomach since then.At routine follow-up in (b)(6) 2022, the patient presented with a possible type ia endoleak.The physician plans to re-intervene but surgery has not been scheduled.
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.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 shows the reported type ia endoleak was confirmed.The reported additional endovascular procedure was not confirmed.This is moderately consistent with the reported adverse event/incident.Procedure-related harms, device, user, procedure, or anatomy relatedness of this event could not be determined with the medical records available for review.The patient had a recent trauma (fall) which could have caused the stent buckling of the suprarenal extension, leading to the type ia endoleak; however the exact cause of the event could not be determined due to lack of medical information surrounding the event.The final patient status post re-intervention was reported as 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.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of an afx2 bifurcated stent graft and an afx vela suprarenal proximal extension.Approximately two and a half (2.5) years post initial procedure in (b)(6) 2022, the patient fell down and suffered a hematoma in the femoral area.Patient started feeling beats in the stomach since then.At routine follow-up in (b)(6) 2022, the patient presented with a possible type ia endoleak.The physician plans to re-intervene but surgery has not been scheduled.Additional information: the physician elected to treat the patient by implanting two (2) 4mm x 33mm bare metal (non-endologix) stents in the left renal artery via chimney technique, and implanting one (1) endurant ii (non-endologix) device at the proximal portion of the stent graft system.Balloon touch-up was performed and the endoleak was successfully resolved.The patient was reportedly stable post re-intervention.

• 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: 15802053
• Report Number: 2031527-2022-00263
• Device Sequence Number: 7074587
• Product Code: MIH
• UDI-Device Identifier: 00818009013620
• UDI-Public: (01)00818009013620(17)220517
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2022

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: 05/17/2022
• Device Model Number: A25-25/C95-O20 V
• Device Lot Number: 2249099-006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/24/2022
• Supplement Date Received by Manufacturer: 12/20/2022
• Initial Report FDA Received Date: 11/15/2022
• Supplement Report FDA Received Date: 03/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2019
• 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 BIFURCATED STENT GRAFT, SN (B)(6)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Male