MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-80/I16-40
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in this 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 a bifurcated stent graft, suprarenal aortic extension and a limb extension to treat an abdominal aortic aneurysm (aaa).Approximately four (4) years post initial procedure, during a routine follow up, a computed tomography angiogram (cta) identified a type 3b endoleak.Patient is stable and currently being monitored while an intervention is being discussed.
Additional Manufacturer Narrative
Device iteration is afx2.Please remove from your complaint system as there was no device failure this is no longer considered a complaint.Corrections: b5: describe event or problem has been updated.G4: date received by manufacturer has been updated.H6: patient code: remove code 1924.H6: device code: remove code 1504.H6: result code: remove code 3233.H6: conclusion code: remove code 11.
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft, suprarenal aortic extension and a limb extension to treat an abdominal aortic aneurysm (aaa).Approximately four (4) years post initial procedure, during a routine follow up, a computed tomography angiogram (cta) identified a type 3b endoleak.Patient is stable and currently being monitored while an intervention is being discussed.Additional information: review of ct scan dated (b)(6) 2021 determined the subject has intact graft with graft fabric billowing posteriorly in the distal main body above the bifurcation with no visible endoleak.Billowing is expected of the stent graft, and is not a defect.Please remove from your complaint system as there was no device failure this is no longer considered a complaint.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 11346104
• Report Number: 2031527-2021-00054
• Device Sequence Number: 16325882
• Product Code: MIH
• UDI-Device Identifier: 00818009014467
• UDI-Public: (01)00818009014467(17)171111
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 01/27/2021

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: 11/11/2017
• Device Model Number: BEA28-80/I16-40
• Device Lot Number: 1614546019
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 02/18/2021
• Supplement Report FDA Received Date: 04/02/2021
• 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: ILIAC LIMB, LOT # 1484383024; SUPRARENAL AORTIC EXTENSION, LOT # 1298616018
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR