MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BA25-100/I16-40
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Aneurysm (1708); Insufficient Information (4580); Clinical Endoleak (4843)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation.It is assumed that the devices remain implanted in the patient.Patient medical records and imaging studies will be requested for further evaluation by a clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Device iteration is afx2.H3 other text : device remains implanted.
Event or Problem Description
The patient was treated for an abdominal aortic aneurysm (aaa) and a right common iliac artery aneurysm on (b)(6) 2017.A gore (non-endologix) excluder leg was deployed then the afx bifurcated stent graft (bsg) and an unknown afx vela were implanted.This initial procedure is outside the indications for use (off-label) due to the use of adjunctive devices not compatible with the afx system.Reportedly, the afx bsg was possibly forced into the anterior aorta wall and migrated.The distributor did not provide further details.
Additional Manufacturer Narrative
The reported 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 device was not returned to endologix for evaluation because the device remains implanted in the patient.A clinical evaluation of the adverse event/incident was completed.An examination of the hand drawn procedure planning received by endologix could not confirm the reported aneurysm enlargement, type ia endoleak, migration, and reintervention.Device, user, procedure or anatomy relatedness of this complaint could not be determined.Procedure related harms for this complaint could not be determined.The final patient status was reported in stable condition.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.D4: model number ¿ corrected.D10: therapy dates and concomitant devices ¿ removed gore and afx vela.G3: awareness date ¿ updated.H6: health effect - clinical code ¿ remove 4580.H6: health effect - impact code ¿ remove 4648.H6: health effect - impact code ¿ remove code 4614.H6: investigation finding codes - remove code 3233.H6: investigation conclusion codes - remove code 11.
Event or Problem Description
The patient was treated for an abdominal aortic aneurysm (aaa) and a right common iliac artery aneurysm on (b)(6) 2017.A gore (non-endologix) excluder leg was deployed then the afx2 bifurcated stent graft (bsg) and an unknown afx vela were implanted.This initial procedure is outside the indications for use (off-label) due to the use of adjunctive devices not compatible with the afx system.Reportedly, the afx2 bsg was possibly forced into the anterior aorta wall and migrated.The distributor did not provide further details.After the initial procedure, the distributor provided additional information to clarify the event.The patient was treated for an abdominal aortic aneurysm (aaa) and a right common iliac artery aneurysm on (b)(6) 2017 with the implant of an afx bifurcated stent graft.Reportedly, the afx2 bsg was possibly forced into the anterior aorta wall and migrated.In (b)(6) 2022, a computerized tomography scan identified aneurysm enlargement with a type ia endoleak caused by the migration.On (b)(6) 2022, reintervention was completed with the implant of a non-endologix endurant aui stent graft and fem-fem bypass was performed.The patient's current condition is stable.

• 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: 17302005
• Report Number: 2031527-2023-00177
• Device Sequence Number: 3784982
• Product Code: MIH
• UDI-Device Identifier: 00818009010032
• UDI-Public: (01)00818009010032(17)191027
• 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: 2017
• 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): 06/22/2023

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: 10/27/2019
• Device Model Number: BA25-100/I16-40
• Device Lot Number: 1605760003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2023
• Supplement Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 10/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2016
• 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 (LN UNK); GORE EXCLUDER LEG (LN UNK)
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown