MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA25-70/I16-30
Medical Device Problem Codes	Use of Device Problem (1670); Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted in the patient; therefore, it will not be returned for evaluation.Patient medical records and imaging studies will be requested for further evaluation by the 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 implanted with an afx2 bifurcated stent graft and an afx vela suprarenal to treat an abdominal aortic aneurysm (aaa).Approximately one (1) year and nine (9) months post initial implant, a possible type iiia endoleak was identified during routine follow-up.Re-intervention was completed successfully with implant of an afx vela infrarenal.Additionally, there was a type ii endoleak (non-device related) on the final angiogram.The patient will 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.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the type iiia endoleak of the aortic components and type ii endoleak of the lumbar artery are confirmed.This is consistent with the reported adverse event/incident.The most likely causation for the type iiia endoleak of the aortic components is most likely user and anatomy related due to the safety and effectiveness of using a 34mm proximal extension with a 25mm bifurcated stent has not been established per the ifu and the increased infrarenal angulation from 42 to 58 degrees (aortic remodeling).The type ii endoleak is anatomy related and is not a device related failure.The final patient status was not reported.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.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 10928640
• Report Number: 2031527-2020-00353
• Device Sequence Number: 11002959
• Product Code: MIH
• UDI-Device Identifier: 00818009014870
• UDI-Public: (01)00818009014870(17)190717
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2020

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: 07/17/2019
• Device Model Number: BEA25-70/I16-30
• Device Lot Number: 1957708002
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/02/2020
• Supplement Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 01/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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 SUPRARENAL (LN 1942978007); AFX VELA SUPRARENAL (LN 1942978007)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR