MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA28-100/I16-40
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	04/12/2021
Type of Reportable Event	Serious Injury
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 afx with duraply.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the afx abdominal aortic aneurysm stent system.Approximately five (5) years post initial procedure, the patient presented with an aneurysm enlargement (5.7mm to 7.5mm) and a suspect type iiib endoleak.The patient is reportedly in good condition, and a re-intervention is currently scheduled.
Additional Manufacturer Narrative
Device iteration is afx with duraply.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 treated for an abdominal aortic aneurysm (aaa) with the afx abdominal aortic aneurysm stent system.Approximately five (5) years post initial procedure, the patient presented with an aneurysm enlargement (5.7mm to 7.5mm) and a suspect type iiib endoleak.The patient is reportedly in good condition, and a re-intervention is currently scheduled.Additional information: review of angiogram dated 30apr2021 found no endoleak.The physician elected to implant an alto main body stent graft and three (3) ovation ix iliac limbs to treat the aneurysm enlargement.The patient was reported as doing well post secondary procedure.A complaint is not warranted since there is no alleged deficiency related to identity, quality, durability, reliability, safety, effectiveness, or performance of the device.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 11734993
• Report Number: 2031527-2021-00180
• Device Sequence Number: 3765341
• Product Code: MIH
• UDI-Device Identifier: 00818009010049
• UDI-Public: (01)00818009010049(17)180408
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 04/12/2021

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: 04/08/2018
• Device Model Number: BA28-100/I16-40
• Device Lot Number: 1320915-027
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 05/02/2021
• Initial Report FDA Received Date: 04/27/2021
• Supplement Report FDA Received Date: 05/04/2021
• 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-0006-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX LIMB STENT GRAFT, SN (B)(4).; AFX LIMB STENT GRAFT, SN (B)(4).; AFX VELA SUPRARENAL, SN (B)(4).
• Outcome Attributed to Adverse Event: Other
• Patient Age: 87 YR