MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-120/I16-40
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	01/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in this event will not be returned for evaluation as it remains implanted in the patient.Patient medical records and imaging studies will be requested for further evaluation by the 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 implanted with a afx2 bifurcated stent graft and two (2) vela suprarenal stent grafts to treat an abdominal aortic aneurysm (aaa).Approximately 3.5 years post initial procedure during a routine follow up, the patient presented non symptomatic with sac enlargement.Images appear to reveal potential type 1a and 3b endoleaks.Re-intervention is planned but has not been scheduled.Patient is stable.
Event or Problem Description
The patient was initially implanted with a afx2 bifurcated stent graft and two (2) vela suprarenal stent grafts to treat an abdominal aortic aneurysm (aaa).Approximately 3.5 years post initial procedure during a routine follow up, the patient presented non symptomatic with sac enlargement.Images appear to reveal potential type 1a and 3b endoleaks.Re-intervention is planned but has not been scheduled.Patient is stable.Updated information: the reported potential type 1a and 3b endoleaks were refuted.However strut buckling and billowing of the bifurcated stent graft were identified.Also multiple type 2 endoleak (non- device related) from lumbars were identified.
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.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 the reported type 1a endoleak and type 3b endoleak of the bifurcated stent graft were refuted, rather there was a bifurcated stent graft strut buckling and billowing.The sac growth was unconfirmed due to a lack of comparative imaging.This is consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest the sac growth is likely the multi-type 2 endoleak (non- device-related failure) from the lumbar arteries.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 as pending re-intervention.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: result code: remove code 3233.H6: conclusion code: remove code 11.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 11263531
• Report Number: 2031527-2021-00037
• Device Sequence Number: 1167034
• Product Code: MIH
• UDI-Device Identifier: 00818009014443
• UDI-Public: (01)00818009014443(17)180628
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2021

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: 06/28/2018
• Device Model Number: BEA28-120/I16-40
• Device Lot Number: 1709156001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/05/2021
• Supplement Date Received by Manufacturer: 03/05/2021
• Initial Report FDA Received Date: 02/01/2021
• Supplement Report FDA Received Date: 04/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX VELA SUPRARENAL 1679304025; AFX VELA SUPRARENAL 1707797017; AFX VELA SUPRARENAL 1679304025; AFX VELA SUPRARENAL 1707797017
• Outcome Attributed to Adverse Event: Other
• Patient Age: 73 YR