MAUDE Adverse Event Report: ENDOLOGIX AFX2; AFX2 BIFURCATED STENT GRAFT

Model Number	BEA25-70/I16-30
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Codes	Failure of Implant (1924); Occlusion (1984); Pain (1994); Thrombus (2101)
Date of Event	11/02/2020
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 the afx2 abdominal aortic aneurysm stent.Approximately one (1) year post initial procedure, the patient presented with severe abdominal and back pain, and coldness in the lower extremities.A component separation (classified as a type iiia endoleak) was detected.The physician elected to treat the patient by aortofemoral bypass surgery on (b)(6) 2020.Patient is reportedly recovering well, but thrombus is still present from the mid-aorta to the femoral arteries.It is unknown if the physician plans to treat the patient further.
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 that the reported type 3a endoleak of the aortic components and the intra stent thrombus from the renal arteries to the bilateral femoral arteries causing complete aortic occlusion were confirmed.This is consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest sac growth of 13mm that was not included in the event as reported.The sac growth was discovered during review of the 12 month post implant ct scan.Procedure related harms, device, user, procedure or anatomy relatedness of this complaint could not be determined with the medical records available for review.The final patient status was reported to be improving following a secondary procedure however intra stent thrombus was still present.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.Corrections: describe event or problem has been updated.Result code: remove code 3233.Conclusion code: remove code 11.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the afx2 abdominal aortic aneurysm stent.Approximately one (1) year post initial procedure, the patient presented with severe abdominal and back pain, and coldness in the lower extremities.A component separation (classified as a type iiia endoleak) was detected.The physician elected to treat the patient by aortofemoral bypass surgery on (b)(6) 2020.Patient is reportedly recovering well, but thrombus is still present from the mid-aorta to the femoral arteries.It is unknown if the physician plans to treat the patient further.Additional information: the reported intra-stent thrombus from the renal arteries to the bilateral femoral arteries caused complete aortic occlusion and there was sac growth of 13mm that was not included in the event as reported.

• Brand Name: AFX2
• Common Device Name: AFX2 BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 10920404
• Report Number: 2031527-2020-00351
• Device Sequence Number: 2671570
• Product Code: MIH
• UDI-Device Identifier: 00818009014870
• UDI-Public: (01)00818009014870(17)200906
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Other,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2020

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: 09/06/2022
• Device Model Number: BEA25-70/I16-30
• Device Lot Number: 2284809-004
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/05/2020
• Supplement Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 11/30/2020
• Supplement Report FDA Received Date: 02/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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, SN (B)(4) ; AFX VELA SUPRARENAL, SN (B)(4)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR