MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA INFRARENAL

Model Number	A25-25/C75V
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Integrity Problem (2978); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/21/2022
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 afx bifurcated stent graft and an afx vela infrarenal proximal extension.Approximately six and a half (6.5) years post initial procedure, the physician explanted the devices.The patient is reportedly doing fine.It is unknown what prompted the explant procedure or if the devices are available for return/evaluation.No additional information is currently available regarding this initial report.Note: as the exact date of event (nor date when device was explanted) is unknown, the best estimate was used, which is the manufacturer awareness date to this event.
Additional Manufacturer Narrative
The devices involved in this event have not be returned for evaluation.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 : devices not returned.
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.An evaluation of the device could not be completed.The explanted device was not returned to endologix for evaluation.A clinical evaluation of the adverse event/incident could not be completed.No medical records nor medical imaging relevant to the reported adverse event/incident was received by endologix.The user facility was unable to provide this information.Due to the absence of medical records and medical imaging; device, use, procedure, and/or anatomy relatedness to this adverse event/incident could not be evaluated, however this event is most likely device related due to the use of strata material.The final patient status was reported as doing fine.A root cause investigation was carried out for all afx complaints having an identified failure mode of a type iiib endoleak.Endologix implemented the following corrective actions with the intent of reducing type iiib endoleak events; 1.Upgraded graft material (i.E.Duraply) and 2.Updates to the ifu and additional physician training.The change to duraply graft material and the ifu changes were put in place july 2014.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 strata.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of an afx bifurcated stent graft and an afx vela infrarenal proximal extension.Approximately six and a half (6.5) years post initial procedure, the physician explanted the devices.The patient is reportedly doing fine.It is unknown what prompted the explant procedure or if the devices are available for return/evaluation.No additional information is currently available regarding this initial report.Note: as the exact date of incident (nor date when device was explanted) is unknown, the best estimate was used, which is the manufacturer awareness date to this event.Additional information: it was reported the vela infrarenal aortic extension had no intact graft material around the stent cage and this was the cause of the endoleak and the subsequent conversion to open repair.Furthermore, the vela stent cage was extended to a significantly larger diameter as there was no limitation due to the lack of sufficient graft material around it.The bifurcated stent graft was not involved in this event.

• 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: 13952807
• Report Number: 2031527-2022-00068
• Device Sequence Number: 4186414
• Product Code: MIH
• UDI-Device Identifier: 00818009013491
• UDI-Public: (01)00818009013491(17)150227
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2022

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: 02/27/2017
• Device Model Number: A25-25/C75V
• Device Lot Number: 1164317-024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/21/2022
• Supplement Date Received by Manufacturer: 04/22/2022
• Initial Report FDA Received Date: 03/30/2022
• Supplement Report FDA Received Date: 05/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2014
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0008-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX BIFURCATED STENT GRAFT, LOT # 1335754-007; AFX VELA INFRARENAL, SN 1164317-024
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown