MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-100/I16-40
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/06/2022
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 afx2 bifurcated stent graft and an afx vela suprarenal.Reportedly, the procedure went well; however, the aortic neck was challenging and there was an existing small dissection in the lcia (left common iliac artery).Final angiogram identified an indeterminate endoleak.The physician has elected to monitor the patient and do a 30 day or 60 follow-up ct (computed tomography) scan.The patient was reported to be discharged one day post procedure.
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 reported adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the indeterminate endoleak was a type ii endoleak (lumbar) unresolved on the 30-day post-index ct scan.This is not consistent with the reported adverse event/incident.Type ii endoleaks are anatomy-related events and are not caused or contributed by the device.Therefore, a complaint is no longer warranted since there is no alleged deficiency related to the identity, quality, durability, reliability, safety, effectiveness, or performance of the device.Device iteration is afx2.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of an afx2 bifurcated stent graft and an afx vela suprarenal.Reportedly, the procedure went well; however, the aortic neck was challenging and there was an existing small dissection in the lcia (left common iliac artery).Final angiogram identified an indeterminate endoleak.The physician has elected to monitor the patient and do a 30 day or 60 follow-up ct (computed tomography) scan.The patient was reported to be discharged one day post procedure.After the initial report, additional information was received reporting that the one (1) month follow-up computerized tomography (ct) scan showed no endoleak.Subsequently, clinical analysis determined that the indeterminate endoleak was a type ii endoleak (lumbar) unresolved on the 30-day post-index ct scan.Type ii endoleaks are anatomy-related events and are not caused or contributed by the device.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.

• 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: 13240041
• Report Number: 2031527-2022-00006
• Device Sequence Number: 4484186
• Product Code: MIH
• UDI-Device Identifier: 00818009014450
• UDI-Public: (01)00818009014450(17)240519
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 01/06/2022

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: 05/19/2024
• Device Model Number: BEA28-100/I16-40
• Device Lot Number: 2460707004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/06/2022
• Supplement Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 01/12/2022
• Supplement Report FDA Received Date: 04/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AFX VELA SUPRARENAL (LN 2428431005)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 83 YR
• Patient Sex: Male