MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA22-70/I16-30
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	01/20/2022
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 aortic stenosis (off-label use due to no abdominal aortic aneurysm) with implant of an afx2 bifurcated stent graft.Results were good at the end of the procedure.Forty-three (43) days post procedure re-occlusion was identified at routine follow-up.Reintervention was completed with thrombolytic therapy only.Reportedly, the patient was in the hospital recovering and will continue to be monitored.
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 aortic occlusion is confirmed.The additional endovascular procedures ((b)(6) 2022) are confirmed.This is moderately consistent with the reported adverse event/incident.The most likely causation for the aortic occlusion is user-related.The procedure relatedness identified was bilateral iliac stenosis requiring bare-metal stents.During the investigation, endologix found reasonable evidence to suggest the device was used off-label.The patient had aortoiliac occlusive disease before the index procedure (off-label use due to no abdominal aortic aneurysm).Additionally, the bare metal stents (non-endologix) placed in the bilateral common iliacs on (b)(6) 2022, were related to the pre-index off-label small diameters (right 5mm and left 5.5mm), should be 10-23mm).The final patient status was discharged on the third post operative day home stable.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: investigation finding codes - remove code 3233.H6: investigation conclusion codes - remove code 11.
Event or Problem Description
The patient was initially treated for aortic stenosis (off-label use due to no abdominal aortic aneurysm) with implant of an afx2 bifurcated stent graft.Results were good at the end of the procedure.Forty-three (43) days post procedure re-occlusion was identified at routine follow-up.Reintervention was completed with thrombolytic therapy only.Reportedly, the patient was in the hospital recovering and will continue to be monitored.After the initial report, additional information was received reporting that the afx2 bifurcated stent graft was free from any clot or thrombus.The patient was in a hyper coagulative state before being treated and is now on plavix and xarelto.The clinical assessment determined that additional reinterventions were performed on (b)(6) 2022 and (b)(6) 2022.Angiogram performed on (b)(6) 2022 identified that the left iliac remained occluded, and the ekos catheter was repositioned.Angiogram performed on (b)(6) 2022 identified that the aorta and iliacs were patent.The ekos catheter was removed, and bilateral bare-metal stents (non-endologix) were implanted into the iliacs (pre-index small diameter non-device related).

• 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: 13359959
• Report Number: 2031527-2022-00017
• Device Sequence Number: 1675246
• Product Code: MIH
• UDI-Device Identifier: 00818009015143
• UDI-Public: (01)00818009015143(17)240726
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 01/20/2022

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: 07/26/2024
• Device Model Number: BEA22-70/I16-30
• Device Lot Number: 2492615R-005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2022
• Supplement Date Received by Manufacturer: 03/07/2022
• Initial Report FDA Received Date: 01/26/2022
• Supplement Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female