MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA22-70/I20-30
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Separation Problem (4043)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Rupture (2208)
Date of Event	03/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted in the patient; therefore, it will not be returned for evaluation.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 treated for an abdominal aortic aneurysm (aaa) with the afx2 bifurcated stent graft and two (2) afx vela suprarenal extensions.The first afx vela was positioned lower than intended; therefore, the second was required.The initial procedural information is not available.Approximately one (1) year post initial procedure, the patient presented with abdominal pain.A computerized tomography and a digital subtraction angiography were performed.Each identified a type iiia endoleak between afx2 and distal afx vela.The type iiia was successfully sealed with a non-endologix (excluder) aortic cuff.Additionally, the patient¿s abdominal pain resided.The patient was reported to be in good condition post re-intervention.
Additional Manufacturer Narrative
Clinical assessment was completed based on the received medical records.The reported type iiia endoleak (aortic) with complete component separation was confirmed.Additionally, it was determined that there was evidence to reasonable suggest an aortic rupture occurred that were not included in the event as reported.The contributing factors for the reported type iiia endoleak could not be determined due to a lack of the relevant medical information (pre ct, implant angiogram and/or operative notes).The contributing factors for the aortic rupture was most likely the type iiia endoleak with complete component separation (aortic).; however, definitive device, user, procedure or anatomy relatedness of this complaint could not be determined.The final patient status was reported being stable post the secondary endovascular procedure.The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device remains implanted; therefore, no device evaluation was completed.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 afx2.Corrections: h6: result code ¿ remove 3233.H6: conclusion code ¿ remove 11.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the afx2 bifurcated stent graft and two (2) afx vela suprarenal extensions.The first afx vela was positioned lower than intended; therefore, the second was required.The initial procedural information is not available.Approximately one (1) year post initial procedure, the patient presented with abdominal pain.A computerized tomography and a digital subtraction angiography were performed.Each identified a type iiia endoleak between afx2 and distal afx vela.The type iiia was successfully sealed with a non-endologix (excluder) aortic cuff.Additionally, the patient¿s abdominal pain resided.The patient was reported to be in good condition post re-intervention.Subsequent to the initial report, clinical assessment determined that there was evidence to reasonable suggest an aortic rupture occurred that were not included in the event as reported.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 10005596
• Report Number: 2031527-2020-00144
• Device Sequence Number: 11598667
• Product Code: MIH
• UDI-Device Identifier: 00818009015105
• UDI-Public: (01)00818009015105(17)181006
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/06/2018
• Device Model Number: BEA22-70/I20-30
• Device Lot Number: 1747687008
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/29/2020
• Supplement Date Received by Manufacturer: 03/29/2020
• Initial Report FDA Received Date: 04/28/2020
• Supplement Report FDA Received Date: 07/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX VELA SUPRARENAL (LN 1765047009); AFX VELA SUPRARENAL (LN 1766780012)
• Outcome Attributed to Adverse Event: Required Intervention