MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA25-110/I20-30
Medical Device Problem Codes	Material Puncture/Hole (1504); Product Quality Problem (1506); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Failure of Implant (1924); Rupture (2208)
Date of Event	04/18/2019
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.If additional information is obtained at a later time that is pertinent to this event, a follow-up report will then be submitted.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the afx abdominal aortic aneurysm stent.Approximately three (3) years post initial procedure, the patient presented emergently with abdominal pain.A type iiib endoleak was identified by a computerized tomography (ct) scan.The patient was successfully relined with a bifurcated afx2 device on (b)(6) 2019.However, the patient continued to experience abdominal pain four (4) hours post secondary implant.No additional information has been provided.Endologix will continue to obtain an update on the patients status.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the afx abdominal aortic aneurysm stent.Approximately three (3) years post initial procedure, the patient presented emergently with abdominal pain.A type iiib endoleak was identified by a computerized tomography (ct) scan.The patient was successfully relined with a bifurcated afx2 device on 18 apr 2019.However, the patient continued to experience abdominal pain four (4) hours post secondary implant.No additional additional information has been provided.Endologix will continue to obtain an update on the patients status.Additional information: at the completion of the clinical assessment, additional findings of a rupture was identified.It was reported that the patient was in good condition post a successful intervention.The reported abdominal pain was resolved.
Additional Manufacturer Narrative
The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned as the device remains implanted therefore no evaluation was completed at the completion of the clinical assessment, the reported type 3b endoleak could not be confirmed with the medical images available for review however an aortic rupture was identified.Procedure related harms, device, user, procedure or anatomy relatedness of this event could not be determined with the medical records /images available for review.No additional investigation of this reported event is planned however if additional information pertinent to the incident is obtained, a follow-up report will be submitted.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.Device iteration is afx with duraply corrections: g1,2: contact office- name has been updated.H6: device code: remove code 2978, 1506.H6: result code: remove code 3221.H6: conclusion code: remove code 11, 12.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8605904
• Report Number: 2031527-2019-00237
• Device Sequence Number: 19566929
• Product Code: MIH
• UDI-Device Identifier: 00818009012234
• UDI-Public: (01)00818009012234(17)181118
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/18/2018
• Device Model Number: BA25-110/I20-30
• Device Lot Number: 1423303-001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/18/2019
• Supplement Date Received by Manufacturer: 04/18/2019
• Initial Report FDA Received Date: 05/13/2019
• Supplement Report FDA Received Date: 04/22/2020
• 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-VELA INFRARENAL:1264386-008.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR