MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-110/I20-30
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	03/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in this event are expected to be returned for evaluation; however, they have not yet been received.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 the implant of an afx2 bifurcated stent graft and an afx vela suprarenal on (b)(6) 2020.The routine follow-up computerized tomography (ct) scan performed on (b)(6) 2022, identified a type iiia endoleak.Reintervention was completed on (b)(6) 2022.An afx vela suprarenal and an afx vela infrarenal were implanted successfully sealing the type iiia endoleak.The patient was reported to be stable post-reintervention (reported under mfr# 2031527-2022-00070).Now approximately one (1) year post-reintervention on (b)(6) 2023, routine follow-up ct scan identified aneurysm growth of 2cm.There was no visible endoleak.The physician elected to explant the devices and perform an open repair.The final patient status was not reported.
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.Endologix performed an evaluation of the returned afx2 bifurcated stent graft and two (2) proximal stent-grafts.The devices were received securely shipped in a biohazard returned container, double-bagged to ensure safety.Upon opening, it was noted that there was evidence of blood and tissue residue on the devices.The devices were decontaminated to eliminate any potential contaminants.A visual analysis was conducted on both the afx2 bifurcated stent graft and the proximal stent grafts.A detailed examination of the stent graft material (eptfe) indicated that there is no observable degradation of the graft material, except for the damage that appeared to have occurred during while explanting the device.No defects were identified in the stent graft material itself.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows aneurysm enlargement and surgical conversion complaints are unconfirmed.This is not consistent with the reported adverse event/incident.However, based on the returned explanted device it is evident that the reported surgical conversion was performed.Procedure related harms, device, user, procedure or anatomy relatedness of this complaint could not be determined with the medical records available for review.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.G3: awareness date ¿ updated h3: device evaluated by mfg - updated h3: device evaluated by mfg - updated h6: investigation type codes - remove code 4118 h6: investigation finding codes - remove code 3233 h6: investigation conclusion codes - remove code 11.

• 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: 16735770
• Report Number: 2031527-2023-00061
• Device Sequence Number: 6663700
• Product Code: MIH
• UDI-Device Identifier: 00818009014542
• UDI-Public: (01)00818009014542(17)200624
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 03/21/2023

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: 06/24/2020
• Device Model Number: BEA28-110/I20-30
• Device Lot Number: 2264670002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2023
• Supplement Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2019
• 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 VELA INFRARENAL (LN 2410264011); AFX VELA SUPRARENAL (LN 2320594016); AFX VELA SUPRARENAL (LN 2476162004)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male