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

Model Number BEA22-70/I16-30

Device Problems Failure To Adhere Or Bond (1031); Leak/Splash (1354)

Patient Problem Failure of Implant (1924)

Event Date 06/07/2018

Event Type  Injury  

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 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.

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
• Type of Device: AFX2 BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 7658248
• MDR Text Key: 113011866
• Report Number: 2031527-2018-00578
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009015143
• UDI-Public: (01)00818009015143(17)180626
• Combination Product (y/n): N
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 06/07/2018
• Initial Date FDA Received: 07/03/2018
• Supplement Dates Manufacturer Received: 08/20/2018
• Supplement Dates FDA Received: 03/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 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)
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR