MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number	A34-34/C80-O20 V
Medical Device Problem Codes	Off-Label Use (1494); Migration (4003)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	11/29/2021
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.Device remains implanted.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with an implant of an afx bifurcated stent graft, and an afx vela suprarenal.Approximately seven (7) years post initial implant the patient presented during a routine follow-up with an implant migration, and a type ia endoleak.The patient was reported to be stable and is being monitored.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with an implant of an afx bifurcated stent graft, and an afx vela suprarenal.Approximately seven (7) years post initial implant the patient presented during a routine follow-up with an implant migration, and a type ia endoleak.The patient was reported to be stable and is being monitored.After the initial report, additional information was received reporting that reintervention was completed.The first alto main body inserted to the patient would not advance over the lunderquist (non-endologix) guidewire.The guidewire was exchanged for a new lunderquist (non-endologix) guidewire; however, the device was still unable to advance.The physician flushed the device multiple times and attempted to take different wires to advance through either end of the alto main body.The wires would go in the back end, but not the correct end to get the alto main body up.The alto main body was removed from the patient.A new alto stent graft system was introduced to the patient and deployed successfully treating the type ia endoleak with migration.The patient was stable post-reintervention.The clinical assessment determined that there was evidence to reasonably suggest sac growth of 6.1mm occurred that was not in the event as reported.This was discovered during a review of the 90-month post-index computerized tomography scan.
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, migration of 56mm of the proximal extension and secondary endovascular procedure are confirmed.This is consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest sac growth of 6.1mm occurred that was not in the event as reported.This was discovered during a review of the 90-month post-index computerized tomography scan.The most likely causation for the type ia endoleak, migration of 56mm of the proximal extension and sac growth is user related.Procedure related harms for this complaint could not be determined.During the investigation, endologix found reasonable evidence to suggest the device was used off-label.The neck length was off-label at 9mm.Per the ifu it should be less than or equal to 15mm.Additionally, there was an impending rupture pre-index procedure- (cautionary product use condition).The final patient status was reported as being in stable condition.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.

• 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: 13011365
• Report Number: 2031527-2021-00499
• Device Sequence Number: 1817035
• Product Code: MIH
• UDI-Device Identifier: 00818009013606
• UDI-Public: (01)00818009013606(17)150213
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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): 11/29/2021

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: 02/13/2015
• Device Model Number: A34-34/C80-O20 V
• Device Lot Number: 1214298024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2021
• Supplement Date Received by Manufacturer: 02/16/2022
• Initial Report FDA Received Date: 12/15/2021
• Supplement Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2014
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX BIFURCATED STENT GRAFT 1053139-008.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Unknown