MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number	A34-34/C80-O20 V
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/01/2022
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, an afx vela suprarenal proximal extension and two (2) ovation ix extenders.This procedure is outside the indications of use (off-label) due to adjunctive devices not compatible with the afx system per ifu.Approximately three and a half (3.5) years post initial procedure, the patient presented with a type ia endoleak.The physician elected to monitor the patient and scan in another 30 days to discern if the endoleak self-resolves.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of an afx2 bifurcated stent graft, an afx vela suprarenal proximal extension and two (2) ovation ix extenders.This procedure is outside the indications of use (off-label) due to adjunctive devices not compatible with the afx system per ifu.Approximately three and a half (3.5) years post initial procedure, the patient presented with a type ia endoleak.The physician elected to monitor the patient and scan in another 30 days to discern if the endoleak self-resolves.After the initial report, it was identified that this event was unintentionally captured as an afx device; therefore, it was filed under the incorrect mfr#.The event has been resubmitted under the correct device (alto) and refiled under mfr# 3008011247-2022-00096.

• 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: 13792519
• Report Number: 2031527-2022-00051
• Device Sequence Number: 11767862
• Product Code: MIH
• UDI-Device Identifier: 00818009013606
• UDI-Public: (01)00818009013606(17)210423
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 03/01/2022

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: 04/23/2021
• Device Model Number: A34-34/C80-O20 V
• Device Lot Number: 1929437-006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2022
• Supplement Date Received by Manufacturer: 08/10/2022
• Initial Report FDA Received Date: 03/17/2022
• Supplement Report FDA Received Date: 08/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2018
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX2 BIFURCATED STENT GRAFT, SN (B)(6); OVATION IX EXTENDER, SN (B)(6); OVATION IX EXTENDER, SN (B)(6)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 83 YR
• Patient Sex: Male