MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-90/I20-30
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	12/12/2022
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 an afx vela infrarenal aortic extension to treat an abdominal aortic aneurysm (aaa).Approximately three (3) years post initial procedure, a possible type 3a or type 1a endoleak was identified (exact date is unknown).A computed tomography (ct) also showed "bird beak" of the proximal portion of the stent graft categorized as bucked materials.The patient is currently stable and being monitored while an intervention is being discussed.
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.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 1a endoleak is confirmed.The type 3a endoleak of the proximal component and main body is unconfirmed.The buckled proximal extension material is confirmed.This is moderately consistent with the reported adverse event/incident.The buckling of the proximal stent was likely due to the sharp aortic angle at implant (63 degrees) - anatomy related.The clinical assessment also determined that there was a type 2 endoleak (non-device related) from the lumbar artery that was not included in the event as reported.The type 2 endoleak was discovered during a review of the post index ct scan.Procedure related harms for this complaint could not be determined.The final patient status was reported as being monitored.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: b5: describe event or problem has been updated g3: awareness date has been updated h6: investigation finding codes: remove code 3233 h6: investigation conclusion codes: remove code 11.
Event or Problem Description
The patient was initially implanted with an afx2 bifurcated stent graft and an afx vela infrarenal aortic extension to treat an abdominal aortic aneurysm (aaa).Approximately three (3) years post initial procedure, a possible type 3a or type 1a endoleak was identified (exact date is unknown).A computed tomography (ct) also showed "bird beak" of the proximal portion of the stent graft categorized as bucked materials.The patient is currently stable and being monitored while an intervention is being discussed.Additional information: an internal clinical assessment determined that there was a type 2 endoleak (non-device related) from the lumbar artery that was not included in the event as reported.The type 2 endoleak was discovered during a review of the post index ct scan.

• 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: 16135234
• Report Number: 2031527-2023-00005
• Device Sequence Number: 6516689
• Product Code: MIH
• UDI-Device Identifier: 00818009014559
• UDI-Public: (01)00818009014559(17)200614
• 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: 2019
• 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): 12/18/2022

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: 06/14/2022
• Device Model Number: BEA28-90/I20-30
• Device Lot Number: 2257526010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2022
• Supplement Date Received by Manufacturer: 01/30/2023
• Initial Report FDA Received Date: 01/10/2023
• Supplement Report FDA Received Date: 03/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2019
• 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: INFRARENAL AORTIC EXTENSION, LOT # 1759545004
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR
• Patient Sex: Male