MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA25-100/I20-40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	12/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was being treated for an abdominal aortic aneurysm (aaa).An endo knot occurred during placement of the afx2 bifurcated stent graft.The physician was unable to resolve the issue; therefore, the afx2 bifurcated stent graft system was removed from the patient.While withdrawing the system the common femoral artery was torn.A new afx2 bifurcated stent graft and an afx vela suprarenal were implanted successfully excluding the aaa.The common femoral artery was repaired with a cut-down and several covered stents as well as a femoral reconstruction.The patient was reported to be stable post procedure.
Additional Manufacturer Narrative
The device involved in this event is being returned for evaluation; however, it has not yet been received.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.
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.The review confirms there were no manufacturing or processing non-conformities identified that would contribute to the reported adverse event/incident.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the reported dissection of the left femoral and iliac arteries is confirmed.This is consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest the following also occurred: the contralateral wire was caught on a thickened calcium shelf, which made manipulating the guidewire impossible.At that point the bifurcated stent graft was deployed outside of the sheath and the delivery system had to be removed through the femoral artery, which caused the dissection.These findings were discovered during an examination of the operative notes dated 15 december 2021.The most likely causation for the reported event is anatomy-related due to the calcifications in the access site and iliac artery (cautionary product use condition).The procedure-related harms identified were abnormal blood loss, possible embolism to the right great toe, acute metabolic encephalopathy and urinary retention.The final patient status was reported as discharged on the fourteenth post-operative day to a skilled nursing facility.An evaluation of the returned devices were completed.A visual and where possible functional analysis was performed post device decontamination.The analysis of the returned devices shows kinks and infoldings throughout the introducer sheath and delivery system, and a partially deployed afx2 bifurcated stent graft.The stent graft was then fully deployed and the delivery system removed from the introducer sheath, both without any issues.The present kinks and infoldings are evidence that resistance may have occurred during advancement or withdrawal of the delivery system.The reported event is likely related to the thickened calcium deposits identified during clinical evaluation.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.Corrections: d9 date received.G6 awareness date.H3 device evaluated by mfg? h3 device ret to mfg for eval? h3 reason device not evaluated; remove data.H6 investigation type codes; remove code 4118.H6 investigation finding codes; remove code 3233.H6 investigation conclusion codes; remove code 11.

• 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: 13113004
• Report Number: 2031527-2021-00511
• Device Sequence Number: 3605697
• Product Code: MIH
• UDI-Device Identifier: 00818009014672
• UDI-Public: (01)00818009014672(17)240623
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 12/15/2021

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: 06/23/2024
• Device Model Number: BEA25-100/I20-40
• Device Lot Number: 2481911002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/15/2021
• Supplement Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 12/29/2021
• Supplement Report FDA Received Date: 03/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2021
• 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: 74 YR
• Patient Sex: Unknown