MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA22-80/I16-40
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	02/15/2024
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 afx2.
Event or Problem Description
The patient was initially treated for a abdominal aortic aneurysm on (b)(6) 2018, with the implant of an afx2 bifurcated stent graft (bsg) and an afx vela suprarenal.A possible type ii endoleak (non-device related) was detected on (b)(6) 2021.An additional afx vela suprarenal implanted as a preventative treatment on (b)(6) 20212.A possible type ii endoleak (non-device related) was identified on (b)(6) 2022.Though an endoleak was not observed on (b)(6) 2022, 5 coils placed in the aneurysm sac.A possible type ii endoleak was detected on (b)(6) 2023.Embolization of lumbars was performed the same day to prevent type ii endoleak.A possible type iiib endoleak was detected on (b)(6) 2024.Reintervention was completed on (b)(6) 2024.The type iiib endoleak was confirmed and the initially implanted afx2 bsg was relined with the implant of an alto abdominal stent graft system.It should be noted that this is off-label treatment due to the use of adjunctive devices not compatible with the afx2 system.Patient status was reported as stable 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 could not perform an evaluation of the device as the device 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 type iiib endoleak complaint is unconfirmed.The additional endovascular procedure complaint is confirmed.This is moderately consistent with the reported adverse event/incident.Device, user, procedure or anatomy relatedness could not be determined.Procedure related harms could not be determined.The afx2 bifurcated stent graft was relined with the implant of an alto abdominal stent graft system.It should be noted that this is off label treatment due to the use of adjunctive devices not compatible with the afx2 system.It was reported that three additional procedures occurred with coiling performed for a non-device related type ii endoleak on 29 june 2021, 07 june 2022, and 14 march 2023.It is unclear if the additional coiling contributed to the reported event.The final patient status 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 afx2.Corrections: g3: awareness date ¿ updated.H6: investigation finding codes - remove code 3233.H6: investigation conclusion codes - remove code 11.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• 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: 18865918
• Report Number: 3011063223-2024-00032
• Device Sequence Number: 18202546
• Product Code: MIH
• UDI-Device Identifier: 00818009015006
• UDI-Public: (01)00818009015006(17)190312
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Recall,Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2024

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 Expiration Date: 03/12/2019
• Device Model Number: BEA22-80/I16-40
• Device Lot Number: 1821423004
• 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: 02/15/2024
• Supplement Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2018
• 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-0007-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX VELA SUPRARENAL (LN 1817883010).; AFX VELA SUPRARENAL (LN 2451388009).; NON-ENDOLOGIX COILS (LN UNK).; NON-ENDOLOGIX UNK EMBOLIZATION.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 89 YR
• Patient Sex: Female