MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-120/I20-40
Medical Device Problem Codes	Off-Label Use (1494); Material Puncture/Hole (1504); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa), with the implant of an afx2 bifurcated stent graft, afx vela infrarenal stent graft, and an afx suprarenal stent graft.Approximately four (4) years post initial procedure, the patient underwent a computed tomography (ct) scan where an endoleak (indeterminate origin) was identified.The patient is currently in stable condition pending a re-intervention.
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.
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 indeterminate endoleak was found to be a type ia endoleak and a type iiib endoleak of the distal main body.This is moderately consistent with the reported adverse event/incident.The distal type iiib endoleak was seen on a 2018 computerized tomography scan.The most likely causation for the type ia endoleak is user related.Procedure related harms for this complaint could not be determined.During the investigation, endologix found reasonable evidence to suggest the device was used off-label.The use of a non-endologix stent in the proximal neck (off label - concomitant use with products outside the ifu) this likely contributed to the type ia endoleak.The final patient status was reported to be in stable condition.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.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa), with the implant of an afx2 bifurcated stent graft, afx vela infrarenal stent graft, and an afx suprarenal stent graft.Approximately four (4) years post initial procedure, the patient underwent a computed tomography (ct) scan where an endoleak (indeterminate origin) was identified.The patient is currently in stable condition pending a re-intervention.After the previously filed report, additional information was received reporting that reintervention was completed with implant of an afx2 bifurcated stent graft and an ovation ix extender.The endoleak was successfully sealed.

• 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: 13538638
• Report Number: 2031527-2022-00036
• Device Sequence Number: 19849549
• Product Code: MIH
• UDI-Device Identifier: 00818009014399
• UDI-Public: (01)00818009014399(17)180629
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2022

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: 06/29/2018
• Device Model Number: BEA28-120/I20-40
• Device Lot Number: 1711388015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2022
• Supplement Date Received by Manufacturer: 03/21/2022
• Initial Report FDA Received Date: 02/15/2022
• Supplement Report FDA Received Date: 04/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2017
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0007-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX VELA INFRARENAL 1252527016; AFX VELA SUPRARENAL 1719342021
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 67 YR
• Patient Sex: Female