MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-90/I16-30
Medical Device Problem Codes	Off-Label Use (1494); Migration (4003); Separation Problem (4043)
Health Effect - Clinical Codes	Failure of Implant (1924); Rupture (2208); Stenosis (2263)
Date of Event	05/24/2022
Type of Reportable Event	Death
Event or Problem Description
The patient was initially implanted with an afx2 bifurcated stent graft and a vela suprarenal to treat an abdominal aortic aneurysm.Approximately (4) four years post initial procedure, the patient was emitted emergently with a type 3a endoleak and rupture aorta.A secondary procedure was completed.The physician elected to implant an afx vela suprarenal.Unfortunately the following day the patient expired.
Additional Manufacturer Narrative
The device remains implanted in the patient; therefore, it will not 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 afx2.Device remains implanted.
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 additional endovascular procedure, ruptured aorta, type iiia endoleak of the aortic components with implant separation and death are confirmed.This is consistent with the reported adverse event/incident.User, procedure or anatomy relatedness of this adverse event could not be determined.The respiratory complications, abnormal blood loss and hemodynamic instability we all related the ruptured aorta that occurred prior to the procedure.The causation for the type iiia endoleak could not be determined.The final patient status was reported as expired on postoperative day one.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.H6: investigation finding codes - remove code 3233.H6: investigation conclusion codes - remove code 11.
Event or Problem Description
The patient was initially implanted with an afx2 bifurcated stent graft and a vela suprarenal to treat an abdominal aortic aneurysm.Approximately (4) four years post initial procedure, the patient was emitted emergently with a type 3a endoleak and rupture aorta.A secondary procedure was completed.The physician elected to implant an afx vela suprarenal.Unfortunately the following day the patient expired.After the follow-up report, additional information was received and clinical evaluation also shows reasonable evidence to suggest migration of the proximal extension (12mm) and aortic stenosis (near occlusion) occurred that was not included in the event as reported.The migration and aortic stenosis were discovered during a review of the computerized tomography scan dated (b)(6) 2022.
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 additional endovascular procedure, ruptured aorta, type iiia endoleak of the aortic components with implant separation and death are confirmed.This is consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest migration of the proximal extension (12mm) and aortic stenosis (near occlusion) occurred that was not included in the event as reported.The migration and aortic stenosis were discovered during a review of the computerized tomography scan dated (b)(6) 2022.The most likely cause of the type iiia endoleak with migration of the proximal stent was aortic remodeling in combination with an off-label neck.There was an increase in the aortic angulation from 30 to 83 degrees (aortic remodeling).The neck was off label as it measured at 9mm long and should be greater than or equal to 15mm.The aortic stenosis was in the severe angulation of the aorta and was related to the separation of the components.The superior stent margin at the index procedure was placed in the aortic angulation, this could have contributed to the type iiia endoleak.The respiratory complications, acute blood loss with hemodynamic instability and death were related to the ruptured aorta that occurred prior to the procedure.The final patient status was reported as expired on postoperative day one.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.B5: describe event or problem - update.G3: awareness date ¿ updated.H6: investigation type codes - remove code 4119.H6: investigation finding codes - remove code 4247.

• 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: 14704842
• Report Number: 2031527-2022-00143
• Device Sequence Number: 12087241
• Product Code: MIH
• UDI-Device Identifier: 00818009014597
• UDI-Public: (01)00818009014597(17)180815
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other,Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/24/2022

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: 08/15/2018
• Device Model Number: BEA28-90/I16-30
• Device Lot Number: 1728870-004
• 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: 05/24/2022
• Supplement Date Received by Manufacturer: 06/29/2022; 07/06/2022
• Initial Report FDA Received Date: 06/15/2022
• Supplement Report FDA Received Date: 07/06/2022; 07/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2017
• 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-0007-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX VELA SUPRARENAL 1776449-006.
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male