MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA25-80/I16-40
Medical Device Problem Codes	Material Puncture/Hole (1504); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Clinical Endoleak (4843)
Date of Event	06/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was initially implanted with an afx2 bifurcated stent graft and a vela a suprarenal aortic extension to treat an abdominal aortic aneurysm (aaa).Approximately eight (8) months post initial procedure, during routine follow up sac enlargement was identified where the aaa measured 43x54mm.The aaa measured 40x50mm prior to the endovascular aortic repair (evar).No endoleak was found during early phase computed tomography (ct) scans; however a recent ct revealed a possible type iiib endoleak around the middle of aneurysm with delayed phase.The patient has not complained about any symptoms.The patient is currently being monitored as an intervention is being planned.
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.
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 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 type iiib endoleak is refuted, rather a type ii endoleak is seen from the lumbar artery.This is not consistent with the reported adverse event/incident.The sac enlargement is 2mm due to a type ii endoleak.This is anatomy related.No procedure related harms for this complaint were identified.The contributing factor for the type ii endoleak is most likely the lumbar artery which was seen in pre ct and arterial phase ct and confirming in delayed phase ct.The final patient status was reported to be under surveillance.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.As the clinical assessment determined that there was a type ii endoleak (non-device related), a complaint is no longer warranted since there is no alleged deficiency related to the identity, quality, durability, reliability, safety, effectiveness, or performance of the device.This event is no longer reportable.Device iteration is afx2.

• 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: 19644666
• Report Number: 3011063223-2024-00098
• Device Sequence Number: 12408952
• Product Code: MIH
• UDI-Device Identifier: 00818009014733
• UDI-Public: (01)00818009014733(17)241207
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Recall,Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2024

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: 12/07/2024
• Device Model Number: BEA25-80/I16-40
• Device Lot Number: 2531989007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/14/2024
• Supplement Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2022
• 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 SUPRARENAL: LOT#: 2617939023
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown