MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA INFRARENAL

Model Number	A25-25/C95V
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	04/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will 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 afx with duraply.
Event or Problem Description
The patient was treated for an abdominal aortic aneurysm (aaa) with implant of an afx2 bifurcated stent graft and an afx vela infrarenal aortic extension on (b)(6) 2023.Approximately six (6) months post initial procedure, a non-contrast ct (computed tomography) images showed the vela aortic extension was partially collapsed and blood to the lower limb appeared to be limited.Contrast ct images were taken and the vela thrombolization was confirmed.They physician then elected to explant both afx2 and vela devices and performed vessel replacement.The current patient status is unknown.
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 returned device was completed.A visual and where possible functional analysis was performed.Detailed visual inspection of the afx2 bifurcated stent graft revealed no punctures.However, it was noted that the connection between the bifurcated stent graft and the vela infrarenal was slightly loose.The vela infrarenal device was inspected, and no significant findings were observed.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows that the vela stent collapse (buckling), thrombus in the aorta and iliacs with aortic and iliac limb stent stenosis complaints are confirmed.The complaint is most likely anatomy related.The explant complaint is unconfirmed.This is moderately consistent with the reported adverse event/incident.Procedure related harms for this complaint could not be determined.The superior stent margin of the main body was placed in the infrarenal angulation (measured 2 months post index at 58 degrees).This combined with the suboptimal placement of the infrarenal proximal extension (8.4mm below right renal artery) likely contributed to the buckling of the stent with resultant thrombus formation and stenosis.The infrarenal proximal extension only had 16.5mm of sealing zone prior to the significant angulation and the addition of the main body.The final patient status was not reported.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 corrections: device avail.For eval? : updated.Date received: updated.Awareness date: updated.Device eval by mfg has been updated.Device ret to mfg has been updated.Investigation finding codes: removed 3233.Investigation conclusion codes: removed 11.

• Brand Name: AFX
• Common Device Name: VELA INFRARENAL
• 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: 19310878
• Report Number: 3011063223-2024-00072
• Device Sequence Number: 19608441
• Product Code: MIH
• UDI-Device Identifier: 00818009013507
• UDI-Public: (01)00818009013507(17)241213
• 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: 2023
• Device Explanted Year: 2024
• 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): 04/19/2024

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: 12/13/2024
• Device Model Number: A25-25/C95V
• Device Lot Number: 2534198013
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2024
• Supplement Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2022
• 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: AFX2 BIFURCATED STENT GRAFT, LOT # 2675243019
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female