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

Model Number	BEA25-110/I20-30
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924); Rupture (2208)
Date of Event	08/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in the 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 an afx2 bifurcated stent graft and a vela suprarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately one (1) year later, the patient presented emergently with symptoms of rupture and a 1b endoleak of the right common iliac artery was identified.An intervention was completed.The physician elected to implant an ovation ix extender to resolve this reported event.The patient was reported as stable post intervention and will continued to be monitored.
Event or Problem Description
The patient was initially implanted with an afx2 bifurcated stent graft and a vela suprarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately one (1) year later, the patient presented emergently with symptoms of rupture and a 1b endoleak of the right common iliac artery was identified.An intervention was completed.The physician elected to implant an ovation ix extender to resolve this reported event.The patient was reported as stable post intervention and will continued to be monitored.Additional information: clinical assessment identified sac growth of 11mm.
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.There are no other equivalent adverse events/incidents for this lot number existing within the endologix complaint handling system.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 the type ib endoleak event is unconfirmed, and the rupture event is confirmed by medical records only.It was unclear from the medical records if the rupture was iliac or aortic, however due to the 11mm sac growth of the aorta and the stable appearance of the right common iliac artery it is most likely the rupture was aortic.The clinical evaluation also shows reasonable evidence to suggest sac growth of 11mm.These findings were discovered during an examination of the post discharge summary dated 21aug2020.Procedure related harms, device, user, procedure or anatomy relatedness of these events could not be determined with the medical records available for review.During the investigation and with the information available, endologix found no evidence to suggest the device was used off-label.The final patient status was reported to be stable.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.

• Brand Name: AFX2
• Common Device Name: AFX2 BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 10538900
• Report Number: 2031527-2020-00260
• Device Sequence Number: 3209019
• Product Code: MIH
• UDI-Device Identifier: 00818009014818
• UDI-Public: (01)00818009014818(17)200624
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2020

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: 06/24/2020
• Device Model Number: BEA25-110/I20-30
• Device Lot Number: 2264671012
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/19/2020
• Supplement Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 09/15/2020
• Supplement Report FDA Received Date: 11/12/2020
• 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: VELA SUPRARENAL, LOT NO. 2269223009; VELA SUPRARENAL, LOT NO. 2269223009
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR