MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA25-90/I16-30
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Lack of Effect (4065)
Health Effect - Clinical Codes	Aneurysm (1708); Clinical Endoleak (4843)
Date of Event	06/02/2023
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.H3 other text : device discarded by the hospital.
Event or Problem Description
The patient was treated for an abdominal aortic aneurysm (aaa) with the implant of an afx bifurcated stent graft and two afx infrarenal aortic extension on (b)(6) 2016.At the one-year follow-up there was no endoleak observed, and the aneurysm measured at 53mm.At the regular follow-up on (b)(6) 2023, the aneurysm measured at 60mm with no apparent endoleak present.On (b)(6) 2023, the distributor received information that based on the computed tomography that with no flow into the aneurysm, a type v endoleak was suspected.On (b)(6) 2023, open surgery was performed and the device was explanted.An endoleak was not confirmed during the procedure; therefore, the aneurysm enlargement was considered to be due to a type v endoleak (endotension).The vascular replacement was completed.
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 explanted devices were not provided to the reporting distributor, and therefore will not be returned to endologix for evaluation.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the aneurysm enlargement complaint is unconfirmed due to a lack of comparative study.As there is evidence of an endoleak, the type v endoleak is refuted and is determined to be an indeterminate endoleak due to suboptimal images (delayed contrast).The explant of afx implants during an open surgery complaint is confirmed from the reported event.This is moderately consistent with the reported adverse event/incident.Device, user, procedure or anatomy relatedness of this complaint could not be determined, and contributing factors were also unable to be identified due to a lack of comparative study.The final patient status was reported as being stable.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 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: 17210597
• Report Number: 2031527-2023-00174
• Device Sequence Number: 5540048
• Product Code: MIH
• UDI-Device Identifier: 00818009010230
• UDI-Public: (01)00818009010230(17)190228
• 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: 2016
• Device Explanted Year: 2023
• 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): 06/09/2023

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: 02/28/2019
• Device Model Number: BA25-90/I16-30
• Device Lot Number: 1414169001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2023
• Supplement Date Received by Manufacturer: 06/28/2023
• Initial Report FDA Received Date: 06/27/2023
• Supplement Report FDA Received Date: 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2016
• 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 INFRARENAL AORTIC EXTENSION (LN 1352043011).; AFX INFRARENAL AORTIC EXTENSION (LN 1379615001).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male