MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA25-80/I16-40
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in the event will not be returned for evaluation as it remains implanted in the patient.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 a vela infrarenal endograft to treat an abdominal aortic aneurysm (aaa).Approximately six (6) months post initial procedure an endoleak was identified during a routine computed tomography (ct) scan.With the overlap having decreased to approximately 4 cm, a type 3a endoleak was suspected.
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.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 type iiia endoleak event is refuted, rather there were multiple type ii endoleaks from the lumbar artery.This is not consistent with the reported adverse event/incident.The most likely causation for the reported event is anatomy-related due to the type ii endoleaks.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 corrections: h6: device code: remove code 3190.H6: result code: remove code 3233.H6: conclusion code: remove code 11.
Event or Problem Description
The patient was initially implanted with an afx2 bifurcated stent graft and a vela infrarenal endograft to treat an abdominal aortic aneurysm (aaa).Approximately six (6) months post initial procedure an endoleak was identified during a routine computed tomography (ct) scan.With the overlap having decreased to approximately 4 cm, a type 3a endoleak was suspected.Additional information: the reported suspected type 3a endoleak was refuted, rather there were multiple type 2 endoleaks from the lumbar artery.As a type ii endoleak is a non device related failure and anatomy-related, this event is no longer reportable to the fda as there is no alleged deficiency related to the identity, quality, durability, reliability, safety, effectiveness, or performance of an endologix device.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 11052089
• Report Number: 2031527-2020-00380
• Device Sequence Number: 17242409
• Product Code: MIH
• UDI-Device Identifier: 00818009014733
• UDI-Public: (01)00818009014733
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Remedial Action: Other,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2020

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: 08/25/2020
• Device Model Number: BEA25-80/I16-40
• Device Lot Number: 2265267-003
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/01/2020
• Supplement Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 12/21/2020
• Supplement Report FDA Received Date: 02/22/2021
• 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 INFRARENAL ENDOGRAFT 2256531015.; AFX VELA INFRARENAL ENDOGRAFT 2256531015
• Outcome Attributed to Adverse Event: Other