MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number BEA28-110/I20-30

Device Problems Collapse (1099); Material Puncture/Hole (1504); Improper or Incorrect Procedure or Method (2017); Device Damaged by Another Device (2915); Appropriate Term/Code Not Available (3191)

Patient Problems Aneurysm (1708); Failure of Implant (1924)

Event Date 01/24/2022

Event Type  Injury  

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.

Event Description

The patient was initially treated for an abdominal aortic aneurysm (aaa) with the afx2 abdominal aortic aneurysm stent, (2) infrarenal aortic extensions and a vela suprarenal.Approximately 2.5 years post initial procedure, an endoleak of indeterminate origin was identified during a routine follow up.Patient is asymptomatic and pending a re-intervention.

Event Description

The patient was initially treated for an abdominal aortic aneurysm (aaa) with the afx2 abdominal aortic aneurysm stent, (2) infrarenal aortic extensions and a vela suprarenal.Approximately 2.5 years post initial procedure, an endoleak of indeterminate origin was identified during a routine follow up.Patient is asymptomatic and pending a re-intervention.After the initial report was submitted, additional information was received reporting that reintervention was completed with the implant of an afx2 bifurcated stent graft and an ovation ix extender.The reline successfully sealed the endoleak.The final patient status was reported as discharged home one day post-intervention.The clinical assessment determined the reported indeterminate endoleak was found to be a distal type iiib endoleak of the main body and a type ii endoleak (non- device related failure) of the lumbar artery.Additionally, there was evidence to reasonably suggest sac growth of 8mm and buckling of the distal main body occurred that was not included in the event as reported.These were discovered during a review of the 40-month post-index computerized tomography scan.

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 indeterminate endoleak was found to be a distal type iiib endoleak of the main body and a type ii endoleak of the lumbar artery.The additional endovascular procedure is confirmed.This is moderately consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest sac growth of 8mm and buckling of the distal main body occurred that was not included in the event as reported.These findings were discovered during an examination of the 40month post-index computerized tomography scan.The most likely causation for the type ii endoleak is anatomy related.The most likely causation for the type iiib endoleak is most likely user related due to the afx infrarenal aortic extension placed in the iliacs at the index procedure (left diameter off label 23.7mm should be 10-23mm).The increased burden with the infrarenal stents in the bilateral iliac arteries on the distal main body most likely caused the buckling.The buckling most likely caused the type iiib endoleak.Procedure related harms for this complaint could not be determined.The final patient status was reported as being discharged one day post-reintervention.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.B2: outcomes attributed to ae - updated b5: describe event or problem - updated e1: physician information (first and last name) - updated g3: awareness date ¿ updated h6: health effect - impact code - updated h6: medical device problem codes - updated h6: investigation finding codes - remove code 3233 h6: investigation conclusion codes - remove code 11.

• Brand Name: AFX2
• Type of Device: 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: 13399209
• MDR Text Key: 285692892
• Report Number: 2031527-2022-00020
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009014542
• UDI-Public: (01)00818009014542(17)200524
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/25/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 05/24/2020
• Device Model Number: BEA28-110/I20-30
• Device Lot Number: 2251536006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2022
• Initial Date FDA Received: 01/31/2022
• Supplement Dates Manufacturer Received: 03/09/2022
• Supplement Dates FDA Received: 03/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: INFRARENAL AORTIC EXTENSION, LOT 1700896002; INFRARENAL AORTIC EXTENSION, LOT 2228398003; VELA SUPRARENAL, LOT 2270987003
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 74 YR
• Patient Sex: Male