MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-90/I20-30
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Clinical Endoleak (4843)
Date of Event	11/12/2022
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 afx2.
Event or Problem Description
The patient was initially treated for a ruptured abdominal aortic aneurysm (aaa) with the implant of an afx2 bifurcated stent graft, an afx vela suprarenal, and an afx vela infrarenal.This initial procedure is contraindicative of the afx2 bifurcated stent graft indications for use as the safety and effectiveness of the system have not been evaluated for patients with ruptured aneurysms.Reportedly, at the index procedure, the patient had a very long renal to aortoiliac bifurcation.Due to the urgent nature of the case it is unknown if the correct size devices were available at the time.A complete seal was obtained at the initial procedure; however, the physician had to cover the left renal.Approximately five (5) years post-initial procedure, the patient presented emergently with abdominal and back pain.A type iiia endoleak with component separation was identified.Reintervention was completed with the implant of an alto abdominal stent graft system and two (2) additional ovation ix iliac limbs.The type iiia endoleak was successfully sealed.The patient's pain was gone, and the patient was expected to be discharged the same day as reintervention or one-day post-reintervention.Reportedly, the patient was doing great.
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 the device 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 iiia endoleak with the additional endovascular procedure is confirmed.This is consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest that at the index procedure on (b)(6) 2017, the malposition of the graft occluding the left renal artery resulted in post operative renal failure.The patient also experienced acute blood loss, respiratory failure, a left upper extremity deep vein thrombus, encephalopathy and additional surgical procedures (abdominal compartment syndrome) that was not included in the event as reported.These events during a review of the discharge summary dated (b)(6) 2017.The type iiia endoleak is most likely anatomy related due to the aortic remodeling.There was an increase in the aortic angle from 35 degrees in 2018 to 86 degrees on (b)(6) 2022.There was also cautionary product use as the patient was ruptured at the index procedure.No procedure related harms for this complaint were identified.The final patient status was discharged to subacute rehabilitation on post operative day fifteen.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.B5: describe event or problem - updated.G3: awareness date ¿ updated.H6: health effect - clinical code ¿ remove code 1924.H6: medical device problem code ¿ remove 3191.H6: investigation finding codes - remove code 3233.H6: investigation conclusion codes - remove code 11.
Event or Problem Description
The patient was initially treated for a ruptured abdominal aortic aneurysm (aaa) with the implant of an afx2 bifurcated stent graft, an afx vela suprarenal, and an afx vela infrarenal.This initial procedure is contraindicative of the afx2 bifurcated stent graft indications for use as the safety and effectiveness of the system have not been evaluated for patients with ruptured aneurysms.Reportedly, at the index procedure, the patient had a very long renal to aortoiliac bifurcation.Due to the urgent nature of the case it is unknown if the correct size devices were available at the time.A complete seal was obtained at the initial procedure; however, the physician had to cover the left renal.Approximately five (5) years post-initial procedure, the patient presented emergently with abdominal and back pain.A type iiia endoleak with component separation was identified.Reintervention was completed with the implant of an alto abdominal stent graft system and two (2) additional ovation ix iliac limbs.The type iiia endoleak was successfully sealed.The patient's pain was gone, and the patient was expected to be discharged the same day as reintervention or one-day post-reintervention.Reportedly, the patient was doing great.After the initial report, the clinical evaluation also shows reasonable evidence to suggest that at the index procedure on (b)(6) 2017, the malposition of the graft occluding the left renal artery resulted in post operative renal failure, acute blood loss, respiratory failure, a left upper extremity deep vein thrombus, encephalopathy and additional surgical procedures (abdominal compartment syndrome) that was not included in the event as reported.(being reported under mfr# 2031527-2023-00017).These events were identified during a review of the discharge summary dated 12/20/2017.

• 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: 15935739
• Report Number: 2031527-2022-00273
• Device Sequence Number: 5027260
• Product Code: MIH
• UDI-Device Identifier: 00818009014559
• UDI-Public: (01)00818009014559(17)180504
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 11/12/2022

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: 05/04/2018
• Device Model Number: BEA28-90/I20-30
• Device Lot Number: 1683479010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2022
• Supplement Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 12/07/2022
• Supplement Report FDA Received Date: 02/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2017
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX VELA INFRARENAL (SN (B)(6).; AFX VELA SUPRARENAL (SN (B)(6).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male