MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA25-80/I20-40
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Codes	Aneurysm (1708); Clinical Endoleak (4843)
Date of Event	09/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of an afx bifurcated stent graft and an afx vela suprarenal proximal extension.Approximately seven and a half (7.5) years post initial procedure, the patient presented with a possible type ib endoleak and aneurysm enlargement of the right common iliac (measuring more than 25mm).The physician elected to treat the patient by relining with an afx2 bifurcated stent graft, one (1) additional afx vela suprarenal and one (1) afx limb stent graft on (b)(6) 2023.Reportedly, the endoleak was successfully resolved and the aneurysm excluded.The patient is reportedly doing well post re-intervention.
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 afx bifurcated stent graft and an afx vela suprarenal proximal extension.Approximately seven and a half (7.5) years post initial procedure, the patient presented with a possible type ib endoleak and aneurysm enlargement of the right common iliac (measuring more than 25mm).The physician elected to treat the patient by relining with an afx2 bifurcated stent graft, one (1) additional afx vela suprarenal and one (1) afx limb stent graft on (b)(6) 2023.Reportedly, the endoleak was successfully resolved and the aneurysm excluded.The patient is reportedly doing well post re-intervention.After the initial report the clinical evaluation also shows reasonable evidence to suggest a type ii endoleak (lumbar) occurred (non-device related) that was not included in the event as reported.These additional findings were discovered during review of the 92-month computed tomography scan ((b)(6) 2023).Also, there was an additional endovascular procedure due to post operative right limb occlusion that was not included in the event as reported.These additional findings were discovered during review of the operative report dated 26 september 2023 (returned to operating room for second procedure).(reported under mfr# 3011063223-2023-00045).
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 possible type ib endoleak is unconfirmed.The aneurysm enlargement and additional endovascular procedure complaints are confirmed.This is consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest that there was a type ii endoleak (lumbar) occurred that was not included in the event as reported.These additional findings were discovered on during review of the 92-month computed tomography scan.The clinical evaluation also shows reasonable evidence to suggest that there was an additional endovascular procedure to treat post-operative right limb occlusion that was not included in the event as reported.These additional findings were discovered during review of the operative report dated 26 september 2023 (returned to operating room for second procedure).The type ii endoleak is anatomy related.Device, procedure, user or anatomy relatedness of the complaint could not be determined.Procedure related harms for this complaint are a right iliac occlusion and additional endovascular procedure (thrombectomy with patch angioplasty (b)(6) 2023).The final patient status was reported as discharge home on postoperative day one.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: b5: describe event or problem - updated.G3: awareness date ¿ updated.H6: investigation finding codes - remove code 3233.H6: investigation conclusion codes - remove code 11.

• Brand Name: AFX
• 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: 17929906
• Report Number: 3011063223-2023-00014
• Device Sequence Number: 6368399
• Product Code: MIH
• UDI-Device Identifier: 00818009012210
• UDI-Public: (01)00818009012210(17)180818
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2023

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: 08/18/2018
• Device Model Number: BA25-80/I20-40
• Device Lot Number: 1283313-027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2023
• Supplement Date Received by Manufacturer: 11/20/2023
• Initial Report FDA Received Date: 10/13/2023
• Supplement Report FDA Received Date: 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2015
• 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-0006-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX VELA SUPRARENAL, SN (B)(6)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male