MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-100/I16-40
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/11/2021
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.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 grafts, two (2) vela suprarenals, and a vela infrarenal to treat an abdominal aortic aneurysm (aaa).Approximately one (1) month post initial implant, the patient was identified with a possible type 3a endoleak.The patient is reported to be doing well pending secondary procedure.
Event or Problem Description
Addition information was received.During the intervention it was determined that the reported type 3a endoleak was a type 2 endoleak.The type ii endoleak was relined with an afx2 bifurcated stent graft, and two (2) afx vela suprarenal.; however, the type ii endoleak was still present at the end of the procedure.Patient is reportedly doing fine.A type 2 endoleak is a non- device related failure and is an anatomy related event therefore this is no longer a reportable event.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.
Additional Manufacturer Narrative
Addition information was received.During the intervention it was determined that the reported type 3a endoleak was a type 2 endoleak.The type ii endoleak was relined with an afx2 bifurcated stent graft, and two (2) afx vela suprarenal.; however, the type ii endoleak was still present at the end of the procedure.Patient is reportedly doing fine.A type 2 endoleak is a non- device related failure and is an anatomy related event therefore this is no longer a reportable event.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
• MDR Report Key: 12338582
• Report Number: 2031527-2021-00313
• Device Sequence Number: 2806329
• Product Code: MIH
• UDI-Device Identifier: 00818009014450
• UDI-Public: (01)00818009014450(17)240305
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 08/11/2021

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: 03/05/2024
• Device Model Number: BEA28-100/I16-40
• Device Lot Number: 2431887-004
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/11/2021
• Supplement Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 08/18/2021
• Supplement Report FDA Received Date: 08/25/2021
• 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 2368133010; AFX VELA SUPRARENAL 2380233002; AFX VELA SUPRARENAL 2380233003; AFX VELA INFRARENAL 2368133010; AFX VELA SUPRARENAL 2380233002; AFX VELA SUPRARENAL 2380233003
• Outcome Attributed to Adverse Event: Other
• Patient Age: 76 YR