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

Model Number	BEA22-40/I13-40
Medical Device Problem Codes	Device-Device Incompatibility (2919); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Stenosis (2263); Claudication (2550)
Date of Event	10/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted in the patient; therefore, it will not be returned for evaluation.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 treated for an abdominal aortic aneurysm (aaa) with an afx2 bifurcated stent graft.Approximately four (4) months post initial procedure the patient presented with claudication.Computed tomography identified aortic stenosis and narrowing of the limbs.Re-intervention was performed with kissing balloon and implant of a non-endologix (gore) vbx balloon expandable endoprosthesis stent in the left common iliac.The patient is doing well post procedure.
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.There are no other equivalent adverse events/incidents for this lot number existing within the endologix complaint handling system.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 the aortic and limb stenosis events are unconfirmed.This is not consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest the concomitant product use of a non-endologix stent in the right external iliac artery.The most likely causation for the aortic and limb stenosis is the pre-existing aorto-iliac occlusive disease and the concomitant product use of a non-endologix stent in the right external iliac artery.The final patient status was reported to be doing well post secondary endovascular procedure.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.G4: date of received by manufacturer has been updated.H6: device code: remove code 3190.H6: result code: remove code 3233.H6: conclusion code: remove code 11.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with an afx2 bifurcated stent graft.Approximately four (4) months post initial procedure the patient presented with claudication.Computed tomography identified aortic stenosis and narrowing of the limbs.Re-intervention was performed with kissing balloon and implant of a non-endologix (gore) vbx balloon expandable endoprosthesis stent in the left common iliac.The patient is doing well post procedure.Additional information: clinical review identified pre-existing aorto-iliac occlusive disease and concomitant product use of a non-endologix stent in the right external iliac artery.

• Brand Name: AFX2
• Common Device Name: AFX2 BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 10786868
• Report Number: 2031527-2020-00321
• Device Sequence Number: 2960508
• Product Code: MIH
• UDI-Device Identifier: 00818009015075
• UDI-Public: (01)00818009015075(17)221216
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/16/2022
• Device Model Number: BEA22-40/I13-40
• Device Lot Number: 2317266007
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/09/2020
• Supplement Date Received by Manufacturer: 12/21/2020
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 12/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR