MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-120/I20-40
Medical Device Problem Codes	Off-Label Use (1494); Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Ruptured Aneurysm (4436); Clinical Endoleak (4843)
Date of Event	12/01/2022
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 afx2.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of an afx bifurcated stent graft, two (2) afx infrarenal aortic extensions and one (1) afx vela suprarenal proximal extension on (b)(6) 2014.Approximately three (3) years post initial procedure, the patient presented with significant aneurysm enlargement (6mm), suprarenal migration (1.5cm) and a distal type iiib endoleak of the bifurcated stent graft.The physician elected to treat the patient by implanting one (1) afx2 bifurcated stent graft, an afx vela infrarenal and one (1) additional afx vela suprarenal on (b)(6)2017.Reference mfr.Report # 2031527-2017-00375 for this secondary intervention event.Approximately one (1) year post secondary intervention, the patient presented with a potential endoleak (at an indeterminate origin).The physician elected to monitor the patient.Reference mfr.Report # 2031527-2018-00415.Then approximately five and a half (5.5) years post secondary intervention, the physician treated the patient for a type iiib endoleak and aortic rupture sometime in (b)(6)2022.This event was discovered during clinical assessment to patient id (b)(6) (mfr.Report # 2031527-2023-00154).The physician elected to repair by implanting a gore (non-endologix) excluder.This report per patient id (b)(6) is to address the tertiary intervention event.
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 afx2, type iiib endoleak, aortic rupture and additional endovascular procedure (with a non-endologix excluder) are confirmed.This is 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.However, this event is deemed device-related per capa 18435.It was also noted there was revision of a previously placed graft (cautionary product use condition).The final patient status was not reported.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: h6 investigation finding codes; remove 3233.H6 investigation conclusion codes; remove 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: 17613364
• Report Number: 2031527-2023-00210
• Device Sequence Number: 7510538
• Product Code: MIH
• UDI-Device Identifier: 00818009014399
• UDI-Public: (01)00818009014399(17)171123
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 08/08/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/23/2017
• Device Model Number: BEA28-120/I20-40
• Device Lot Number: 1619461-007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2023
• Supplement Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 08/24/2023
• Supplement Report FDA Received Date: 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2016
• 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 BIFURCATED STENT GRAFT, SN (B)(6).; AFX INFRARENAL AORTIC EXTENSION, SN (B)(6).; AFX INFRARENAL AORTIC EXTENSION, SN (B)(6).; AFX VELA INFRARENAL, SN (B)(6).; AFX VELA SUPRARENAL, SN (B)(6).; AFX VELA SUPRARENAL, SN (B)(6).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male