MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA25-100/I16-40
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	11/10/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of an afx2 bifurcated stent graft and an afx infrarenal aortic extension.Approximately three (3) and a half years post initial procedure, aneurysm enlargement from 50mm to 62mm was identified with no identifiable endoleak.Though no endoleaks were confirmed on the pre-procedural angiography, reintervention was performed.An excluder (non-endologix) was deployed in the ipsilateral leg and an additional excluder (non-endologix) was deployed in the contralateral leg via left access.Reportedly, the patient continues to be monitored.
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation and 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.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of an afx2 bifurcated stent graft and an afx infrarenal extension.Approximately four (4) and a half years post initial procedure aneurysm enlargement from 50mm to 62mm was identified with no known cause (i.E.Type v endoleak).Though no endoleaks were confirmed on the pre-procedural angiography, reintervention was performed.An excluder (non-endologix) was deployed in the ipsilateral leg and an additional excluder (non-endologix) was deployed in the contralateral leg via left access.Reportedly, the patient continues to be monitored.After the initial report, clinical analysis determined that the indeterminate endoleak was determined to be a type ii endoleak (non-device related (lumbar)) of the lumbar artery.
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 the sac growth of 13mm is confirmed.The indeterminate endoleak was found to be a type ii endoleak of the lumbar artery.The secondary endovascular procedure is unconfirmed.This is moderately consistent with the reported adverse event/incident.The most likely causation for the sac growth and type ii endoleak is anatomy related.Procedure related harms for this complaint could not be determined.The final patient status was reported as being monitored following the 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.B5: describe event or problem - updated.H6: health effect - clinical code: remove 1924.H6: medical device problem codes: remove 3190.H6: investigation finding codes: remove code 3233.H6: investigation conclusion codes: remove code 11.Based on the results of the clinical finding of a type ii endoleak (which caused the sac growth and subsequent re-intervention on (b)(6) 2022) this is no longer a reportable event.

• 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: 13482796
• Report Number: 2031527-2022-00030
• Device Sequence Number: 5363284
• Product Code: MIH
• UDI-Device Identifier: 00818009014726
• UDI-Public: (01)00818009014726(17)181010
• 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: 2018
• 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): 01/31/2022

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: 10/10/2018
• Device Model Number: BEA25-100/I16-40
• Device Lot Number: 1748648-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2022
• Supplement Date Received by Manufacturer: 03/30/2022
• Initial Report FDA Received Date: 02/08/2022
• Supplement Report FDA Received Date: 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2017
• 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 INFRARENAL AORTIC EXTENSION (LN 1673530-001).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male