MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA28-100/I16-40
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Vascular Dissection (3160)
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of an afx bifurcated stent graft, an afx vela suprarenal proximal extension and four (4) afx limb stent graft distal extensions.On an unknown date, the patient had a tevar (thoracic endovascular aortic repair) device placed to treat a dissection.It was also noted that the thoracic aorta was previously stented at the supra-celiac.No additional information is currently available regarding this initial report.
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 afx with duraply.H3 other text: devices remain 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.The review confirms there were no manufacturing or processing non-conformities identified that would contribute to the reported adverse event/incident.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 reported dissection was confirmed as non-device-related.This is moderately consistent with the reported adverse event/incident.It is documented that the patient had a history of type b aortic dissection with multiple repairs, including a tevar for dissection prior to the evar.This finding was discovered during examination of the operative note dated (b)(6) 2016.The most likely causation for the reported event is the patient's thoracic aneurysm.This event can therefore be removed from the fda database as it is no longer reportable.No additional investigation of this reported adverse event/incident is planned.Endologix will continue to monitor this and similar adverse events/incidents.Device iteration is afx with duraply.Corrections: h6 medical device problem codes; remove 3190.H6 investigation finding codes; remove 3233.H6 investigation conclusion codes; remove 11.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of an afx bifurcated stent graft, an afx vela suprarenal proximal extension and four (4) afx limb stent graft distal extensions.On an unknown date, the patient had a tevar (thoracic endovascular aortic repair) device placed to treat a dissection.It was also noted that the thoracic aorta was previously stented at the supra-celiac.No additional information is currently available regarding this initial report.Additional information: internal clinical assessment identified that the patient has a documented history of type b aortic dissection with multiple repairs, including a (pre-existing) tevar for dissection on (b)(6) 2016, which was prior to the evar with endologix devices on (b)(6) 2016.Therefore, a complaint is not warranted since there is no alleged deficiency related to the identity, quality, durability, reliability, safety, effectiveness, or performance of the device.This event is no longer reportable.

• Brand Name: AFX
• 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: 17599960
• Report Number: 2031527-2023-00213
• Device Sequence Number: 6125789
• Product Code: MIH
• UDI-Device Identifier: 00818009010049
• UDI-Public: (01)00818009010049(17)181223
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 08/14/2023

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: 12/23/2018
• Device Model Number: BA28-100/I16-40
• Device Lot Number: 1292995-009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2016
• 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 LIMB STENT GRAFT, SN: (B)(6).; AFX LIMB STENT GRAFT, SN: (B)(6).; AFX LIMB STENT GRAFT, SN: (B)(6).; AFX LIMB STENT GRAFT, SN: (B)(6).; AFX VELA SUPRARENAL, SN: (B)(6).; NON-ENDOLOGIX THORACIC AORTA STENT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female