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

Model Number	BEA25-70/I20-30
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/19/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was initially implanted with an afx2, bifurcated stent graft to treat an abdominal aortic aneurysm (aaa).On (b)(6) 2020, a secondary procedure was preformed for an unknown reason.Two (2) ovation ix, limb stent graft extenders and a non - endologix (gore vbx) stent were implanted.This secondary procedure is outside the indications of use (off-label) due to the use of adjunctive devices not compatible with afx system per the ifu.This secondary procedure was identified during a review of a recently reported adverse event (ref 2031527-2021-00459).Medical images and records were requested.A clinical assessment of the medical records received was completed on (b)(6) 2021.A type 1b endoleak and a type 2 endoleak (non- device related failure) were identified.Both endoleaks were identified to be anatomy related.
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 as 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 identified a type 1b endoleak in the right common iliac artery and type 2 endoleak in the left common iliac artery with a secondary procedure.The most likely causation for both endoleaks was anatomy related.The type 1b endoleak was identified to be anatomy related due to the inferior stent margin was positioned at a sharp angulation and the type 2 endoleak is a non- device related failure.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.

• Brand Name: AFX2
• Common Device Name: AFX2 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: 13242367
• Report Number: 2031527-2022-00007
• Device Sequence Number: 14600862
• Product Code: MIH
• UDI-Device Identifier: 00818009014832
• UDI-Public: (01)00818009014832(17)190110
• Combination Product (Y/N): N
• Initial Reporter State: PA
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/29/2021

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: 01/10/2019
• Device Model Number: BEA25-70/I20-30
• Device Lot Number: 1775300-008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/29/2021
• Initial Report FDA Received Date: 01/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Unknown