MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA25-80/I16-40
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	01/07/2022
Type of Reportable Event	Serious Injury
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 afx with duraply.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of an afx bifurcated stent graft an afx infrarenal aortic extension.Continued aneurysm enlargement was identified at the patient¿s routine follow-ups.The one (1) month ct imaging measured the aneurysm diameter at 55mm.The four (4) year ct imaging measured the aneurysm diameter at 63.5mm.The five (5) year ct imaging measured the aneurysm diameter at 68mm.Approximately two (2) years post initial procedure a possible type ii endoleak (non-device related) or type iiia endoleak was suspected.The physician elected to perform coil embolization on the inferior mesenteric artery and monitor the patient.The scheduling of additional reintervention is undecided and will not be done in the near future.The patient status was not reported.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of an afx bifurcated stent graft an afx infrarenal aortic extension.Continued aneurysm enlargement was identified at the patient¿s routine follow-ups.The one (1) month ct imaging measured the aneurysm diameter at 55mm.The four (4) year ct imaging measured the aneurysm diameter at 63.5mm.The five (5) year ct imaging measured the aneurysm diameter at 68mm.Approximately two (2) years post initial procedure a possible type ii endoleak (non-device related) or type iiia endoleak was suspected.The physician elected to perform coil embolization on the inferior mesenteric artery and monitor the patient.The scheduling of additional reintervention is undecided and will not be done in the near future.The patient status was not reported.Additional information: the indeterminate endoleak was confirmed to be a type 2 endoleak (non-device related issue) of the internal mesenteric artery.A type 2 endoleak is considered a non-device-related issue, therefore this event is no longer considered reportable.
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.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 indeterminate endoleak was confirmed to be a type ii endoleak of the internal mesenteric artery.The additional endovascular procedure complaint is unconfirmed.The sac growth of 13.3mm complaint is confirmed.This is consistent with the reported adverse event/incident.The most likely causation for the aneurysm enlargement and endoleak type ii is anatomy-related.Procedure-related harms of this complaint could not be determined with the medical records available for review.The final patient status remains unknown.The final patient status was not made available to endologix.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.A type 2 endoleak is considered a non-device-related issue, therefore this event is no longer considered reportable.Device iteration is afx with duraply.

• Brand Name: AFX
• 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: 13538250
• Report Number: 2031527-2022-00035
• Device Sequence Number: 4073615
• Product Code: MIH
• UDI-Device Identifier: 00818009010018
• UDI-Public: (01)00818009010018(17)170623
• 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): 02/08/2022

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: 06/23/2014
• Device Model Number: BA25-80/I16-40
• Device Lot Number: 1251742021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2022
• Supplement Date Received by Manufacturer: 04/04/2022
• Initial Report FDA Received Date: 02/15/2022
• Supplement Report FDA Received Date: 04/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2014
• 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 1597765016)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male