MAUDE Adverse Event Report: ENDOLOGIX AFX; AFX2 BIFURCATED STENT GRAFT

Model Number	BEA22-70/I16-30
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Leak/Splash (1354)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted in patient.If additional information pertinent to the event is obtained, a follow-up report will be submitted.
Event or Problem Description
Primary procedure was performed by dr.(b)(6) at (b)(6) medical center, in (b)(6) in (b)(6), on (b)(6) 2017.Patient was implanted with an afx2 bifurcated stent, a afx vela suprarenal, a afx limb stent graft, and an ovation ix extender.On (b)(6) 2018, it was discovered that the patient had a indeterminate endoleak (possible type 3a) between the main body limb and left distal extension.On (b)(6) 2018, the left distal extension was relined with another afx limb stent graft of the same size.Completion angio showed no further evidence of a type 3a endoleak, but did reveal a persistent type 2 endoleak.Patient was reported to be in a stable condition post op.No additional event or patient information is available.
Additional Manufacturer Narrative
An evaluation of the reported event could not be completed due to a lack of receipt of relevant medical records and/or imaging.Requests were made and denied response were received.As such, event determination, off label conditions, related patient harms and patient disposition could not be independently assessed.The review of manufacturing lot confirmed all devices met specifications prior to release.No additional investigations of this reported complaint are planned.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.

• Brand Name: AFX
• Common Device Name: AFX2 BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 7658248
• Report Number: 2031527-2018-00578
• Device Sequence Number: 11420425
• Product Code: MIH
• UDI-Device Identifier: 00818009015143
• UDI-Public: (01)00818009015143(17)180626
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2018

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: Physician
• Device Expiration Date: 06/26/2018
• Device Model Number: BEA22-70/I16-30
• Device Lot Number: 1708017005
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/07/2018
• Supplement Date Received by Manufacturer: 08/20/2018
• Initial Report FDA Received Date: 07/03/2018
• Supplement Report FDA Received Date: 03/09/2019
• 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 LIMB STENT GRAFT (LN 1618787007); AFX VELA SUPRARENAL (LN 1724800013); OVATION IX EXTENDER (LN FS041417-21); AFX LIMB STENT GRAFT (LN 1618787007); AFX VELA SUPRARENAL (LN 1724800013); OVATION IX EXTENDER (LN FS041417-21)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR