MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number	A25-25/C95-O20 V
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	09/15/2021
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 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 suprarenal.On an unknown date the physician attempted to fix a type ii endoleak with coiling the aaa sac.Approximately seven (7) years post initial procedure, aneurysm enlargement with a possible type 3a and type ia endoleak(s), or junction leak between the afx bifurcated stent and the afx vela suprarenal, were identified at routine follow-up.The patient is being monitored and is pending scheduled reintervention.
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 device could not be completed.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 type ia endoleak, type iiia endoleak, sac growth of 29.4mm and additional endovascular procedure on 11/04/2021 adverse event/incident are confirmed.This is consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest two (2) endovascular procedures occurred in 2017 and 2019 for treatment of type ii endoleaks (one confirmed to be the internal mesenteric artery (non- device related failure)) occurred and only one was included in the event as reported.These findings were discovered during an examination of the discharge summary dated 11/05/2021.The most likely causation for type iiia endoleak is anatomy related.There was poor stent to stent apposition on the one-month post ct scan due to the aortic angulation and placement of the main body (anatomy related).The angulation increased from 37 to 55 degrees.There were thickened calcifications in the aortic neck (cautionary product use condition).This could have contributed to the type ia endoleak; however, that could not be verified.No procedure related harms for this adverse event/incident could be determined.The final patient status was discharged on the first post-operative day home stable following the secondary endovascular procedure.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 suprarenal.On an unknown date the physician attempted to fix a type ii endoleak with coiling the aaa sac.Approximately seven (7) years post initial procedure, aneurysm enlargement with a possible type 3a and type ia endoleak(s), or junction leak between the afx bifurcated stent and the afx vela suprarenal, were identified at routine follow-up.The patient is being monitored and is pending scheduled reintervention.Subsequent to the initial report, reintervention was completed with implant of an afx2 bifurcated stent graft and an afx vela suprarenal.The patient was reported to be doing well post-reintervention.Additionally, clinical assessment determined that there was evidence to reasonably suggest two (2) endovascular procedures occurred in 2017 and 2019 for treatment of type ii endoleaks (one confirmed to be the internal mesenteric artery (non- device related failure)) occurred and only one was included in the event as reported.The type ii endoleaks and endovascular procedures were discovered during a review of the discharge summary dated (b)(6) 2021.

• Brand Name: AFX
• Common Device Name: VELA SUPRARENAL
• 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: 12571990
• Report Number: 2031527-2021-00422
• Device Sequence Number: 3913663
• Product Code: MIH
• UDI-Device Identifier: 00818009013620
• UDI-Public: (01)00818009013620(17)150519
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall,Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2021

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: 05/19/2015
• Device Model Number: A25-25/C95-O20 V
• Device Lot Number: 1246581-025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2021
• Supplement Date Received by Manufacturer: 12/29/2021
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 01/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2014
• 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 (LN 1264290-010)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Female