MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA25-100/I20-40
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Codes	Aneurysm (1708); Pain (1994); Clinical Endoleak (4843)
Date of Event	08/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2016 the patient was treated for an abdominal aortic aneurysm (aaa) with the implant of an afx2 bifurcated stent graft (bsg), an afx vela suprarenal and an afx limb stent graft.Reportedly, the patient was lost to follow-up.On (b)(6) 2023 the patient presented emergently with back pain.The computed tomography angiography identified separation of the afx2 bsg and the afx vela suprarenal.Reintervention was completed on (b)(6) 2023 with the implant of two (2) afx vela infrarenal, and afx vela suprarenal and an afx limb stent graft.Reportedly, the patient did well was discharged the next day.
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.
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.An evaluation of the device could not be completed.The device was not returned to endologix for evaluation because the device 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 implant separation (proximal extension and main body), type iiia endoleak and additional endovascular procedure complaints are confirmed.This is consistent with the reported adverse event/incident.The clinical assessment determined that there was evidence to reasonable suggest aneurysm enlargement of 44.6mm occurred that was not included in the event as reported.The aneurysm enlargement was discovered during review of the computed tomography scan dated (b)(6) 2023.The complaint is most likely anatomy related.The mid aortic angle increased from 38.4° at index to 53.2°.This (anatomy related) aortic remodeling likely contributed to the reported event.Additionally, there was cautionary product use as the patient was reportedly lost to follow-up.No procedure related harms were identified.The final patient status was reported as discharged home on postoperative day three in stable and improved condition.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.H6: investigation finding codes - remove code 3233.H6: investigation conclusion codes - remove code 11.
Event or Problem Description
On (b)(6) 2016 the patient was treated for an abdominal aortic aneurysm (aaa) with the implant of an afx2 bifurcated stent graft (bsg), an afx vela suprarenal and an afx limb stent graft.Reportedly, the patient was lost to follow-up.On (b)(6) 2023 the patient presented emergently with back pain.The computed tomography angiography identified separation of the afx2 bsg and the afx vela suprarenal.Reintervention was completed on (b)(6) 2023 with the implant of two (2) afx vela infrarenal, and afx vela suprarenal and an afx limb stent graft.Reportedly, the patient did well was discharged the next day.After the initial report, the clinical assessment determined that there was evidence to reasonable suggest aneurysm enlargement of 44.6mm occurred that was not included in the event as reported.The aneurysm enlargement was discovered during review of the computed tomography scan dated (b)(6) 2023.

• 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: 17730421
• Report Number: 2031527-2023-00225
• Device Sequence Number: 12362114
• Product Code: MIH
• UDI-Device Identifier: 00818009014672
• UDI-Public: (01)00818009014672(17)170606
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 08/20/2023

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: 06/06/2017
• Device Model Number: BEA25-100/I20-40
• Device Lot Number: 1491488017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2023
• Supplement Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 09/12/2023
• Supplement Report FDA Received Date: 11/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2016
• 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 LIMB STENT GRAFT (LN 1361096009).; AFX VELA SUPRARENAL (LN 1491539009).
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male