MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA25-80/I16-40
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	08/24/2024
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 an afx2 bifurcated stent graft and a vela suprarenal to treat an anastomotic pseudoaneurysm.Approximately one and a half (1.5) years post initial procedure the afx2 bifurcated stent graft and a vela suprarenal were confirmed as having an overall thrombus occlusion.The physician elected to remove the thrombus using a fogarty (non-endologix) catheter; however, the thrombus was not completely removed.A gore excluder (non-endologix) stent was placed and the procedure was completed.The physician noted that there was no flexion or stenosis in the afx stent graft.The physician also noted that the patient was suffering from dehydration due to farm work, which is thought to be the cause.The final patient status was not provided.
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 graft occlusion (extending into iliacs bilaterally) complaint is confirmed, and the additional endovascular procedure is unconfirmed.This is moderately consistent with the reported adverse event/incident.It was reported that the patient was implanted with afx and vela to treat an anastomotic pseudoaneurysm of a previously implanted y-shaped artificial vessel.It is unclear if this concomitant product use contributed to the reported event.A 25x80mm main body was placed with a 25x75 suprarenal stent was placed at the index procedure.The ifu states when selecting a 22-, 25-, or 28-mm proximal extension, a diameter one size larger than the main body of the bifurcated stent graft is recommended.It is unclear if this product choice contributed to the reported event.Device, user, procedure or anatomy relatedness of the complaint could not be determined.Procedure related harms could not be determined.The final patient status was not reported.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: g3: date received by manufacturer has been updated.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
• Manufacturer (Section G): ENDOLOGIX; 2 musick; ,; irvine CA 92618
• Manufacturer Contact: gary kirchgater ; 2 musick; ,; irvine, CA 92618 ; 8009832284
• MDR Report Key: 20248465
• Report Number: 3011063223-2024-00139
• Device Sequence Number: 17950622
• Product Code: MIH
• UDI-Device Identifier: 00818009013576
• UDI-Public: (01)00818009013576(17)250414
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2024

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: 04/14/2026
• Device Model Number: BEA25-80/I16-40
• Device Lot Number: 2540131009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2022
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX VELA SUPRARENAL, LOT # 2567058019.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male