MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA28-90/I16-30
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190); Separation Problem (4043)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	03/17/2020
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 afx with duraply.Device remains implanted in patent.
Event or Problem Description
The patient was initially implanted with an afx bifurcated stent graft and a vela suprarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Four (4) years post initial procedure, a type 3a endoleak was identified.An intervention was completed.The physician elected to reline the original implanted devices with an afx2 bifurcated stent graft, a vela suprarenal, and a vela infrarenal stent graft extension to resolve this event.The patient did well.
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, there was evidence to reasonably suggest sac growth of 20mm occurred that was not included in the event as reported.The type iiia endoleak is most likely anatomy related as the pre computerized tomography scan showed an infrarenal neck of 51 degrees, by 48 months post implant the aorta became dual angled at 121 and 61 degrees respectively, demonstrating aortic remodeling likely contributed to this event.The sac growth was due to the type iiia endoleak.Procedure related harms for this complaint could not be determined.The final patient status was reported to be well following a 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 afx with duraply.Corrections: b5: describe event or problem ¿ updated.H6: result code ¿ remove 3223.H6: conclusion code ¿ remove 11.
Event or Problem Description
The patient was initially implanted with an afx bifurcated stent graft and a vela suprarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Four (4) years post initial procedure, a type 3a endoleak was identified.An intervention was completed.The physician elected to reline the original implanted devices with an afx2 bifurcated stent graft, a vela suprarenal, and a vela infrarenal stent graft extension to resolve this event.The patient did well.Subsequent to the initial report, clinical assessment determined there was evidence to reasonably suggest sac growth of 20mm occurred that was not included in the event as reported.Additionally, the type 3a endoleak included complete component separation.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 9955714
• Report Number: 2031527-2020-00137
• Device Sequence Number: 11372077
• Product Code: MIH
• UDI-Device Identifier: 00818009010247
• UDI-Public: (01)00818009010247(17)181211
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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): 03/17/2020

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: 12/11/2018
• Device Model Number: BA28-90/I16-30
• Device Lot Number: 1265993-033
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/17/2020
• Supplement Date Received by Manufacturer: 03/17/2020
• Initial Report FDA Received Date: 04/13/2020
• Supplement Report FDA Received Date: 06/30/2020
• 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 SUPRARENAL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR