MAUDE Adverse Event Report: ENDOLOGIX, INC. AFX; BIFURCATED STENT GRAFT

Model Number	BA28-70/I16-30
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aneurysm (1708); Rupture (2208)
Date of Event	07/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in the 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 afx with duraply.
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft, a suprarenal stent graft extension and an infrarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately three (3) years post initial procedure, sac growth with no obvious leak was reported.No further information was reported.Additional information has been requested.
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 sac growth event was unconfirmed due to a lack of relevant medical imaging and records however there was evidence to reasonably suggest a rupture.Procedure related harms, device, user, procedure or anatomy relatedness of this complaint could not be determined due to a lack of relevant medical imaging and records.The final patient status was not reported.The final patient status was not reported.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.
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft, a suprarenal stent graft extension and an infrarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately three (3) years post initial procedure, sac growth with no obvious leak was reported.No further information was reported.Additional information has been requested.Additional information: a clinical assessment determined that there was evidence to reasonably suggest a rupture.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 8907094
• Report Number: 2031527-2019-00370
• Device Sequence Number: 2548589
• Product Code: MIH
• UDI-Device Identifier: 00818009010117
• UDI-Public: (01)00818009010117(17)181223
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/23/2018
• Device Model Number: BA28-70/I16-30
• Device Lot Number: 1297653-014
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/25/2019
• Supplement Date Received by Manufacturer: 07/25/2019
• Initial Report FDA Received Date: 08/19/2019
• Supplement Report FDA Received Date: 06/12/2020
• 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: VELA INFRARENAL, LOT 1382613018; VELA SUPRARENAL, LOT 1446271012; VELA INFRARENAL, LOT 1382613018; VELA SUPRARENAL, LOT 1446271012
• Outcome Attributed to Adverse Event: Other
• Patient Age: 81 YR