MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-80/I20-40
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Material Puncture/Hole (1504); Lack of Effect (4065)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	01/04/2023
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
On (b)(6) 2016, the patient was treated for an abdominal aortic aneurysm (aaa) with the implant of an afx2 bifurcated stent graft and an afx vela suprarenal.On (b)(6) 2023, aneurysm enlargement with distal movement of the afx2 bifurcated stent graft of approximately 1-2cm was identified at routine follow-up.Successful reintervention was completed on (b)(6) 2023, with the implant of an afx2 bifurcated stent graft and an afx vela suprarenal.Patient was discharged one day post-reintervention.
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 incident was completed.An examination of medical records and/or medical imaging received by endologix shows the afx2, aneurysm enlargement of 9.7 mm and additional endovascular procedure is confirmed.The reported migration of the proximal extension is refuted.The implant angiogram showed superior stent margin of the proximal extension was at the base of the most proximal right renal artery.The computerized tomography scan dated (b)(6) 2022, showed the placement of the proximal extension to be the same.Therefore, there was no migration of the proximal extension, rather there was suboptimal placement of the stent at index.This is moderately consistent with the reported incident.The clinical evaluation also shows reasonable evidence to suggest a type iiib endoleak of both the proximal extension and main body occurred that was not included in the event as reported.The type iiib endoleaks were discovered on during a review of the computed tomography scan dated (b)(6) 2022.Device, user, procedure, or anatomy relatedness of this complaint could not be determined.Procedure related harms for this complaint could not be determined.The final patient status was reported to be discharge to 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 afx2.B5: describe event or problem - updated.G3: awareness date ¿ updated.H6: medical device problem codes ¿ remove code 1395.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 and an afx vela suprarenal.On (b)(6) 2023, aneurysm enlargement with distal movement of the afx2 bifurcated stent graft of approximately 1-2cm was identified at routine follow-up.Successful reintervention was completed on (b)(6) 2023, with the implant of an afx2 bifurcated stent graft and an afx vela suprarenal.Patient was discharged one day post-reintervention.After the initial report, the clinical assessment determined that there was evidence to reasonably suggest a type iiib endoleak of both the proximal extension and main body occurred that was not included in the event as reported.The type iiib endoleaks were discovered on during a review of the computed tomography scan dated (b)(6) 2022.

• 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: 16261625
• Report Number: 2031527-2023-00013
• Device Sequence Number: 20529410
• Product Code: MIH
• UDI-Device Identifier: 00818009014412
• UDI-Public: (01)00818009014412(17)17051
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2023

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: 05/16/2017
• Device Model Number: BEA28-80/I20-40
• Device Lot Number: 1354863007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2023
• Supplement Date Received by Manufacturer: 03/06/2023
• Initial Report FDA Received Date: 01/28/2023
• Supplement Report FDA Received Date: 03/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2016
• 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; Z-0008-2019
• 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