MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number	A34-34/C100-O20 V
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	05/14/2016
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.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
Endologix was made aware of patient with an undetermined endoleak with sac growth on (b)(6) 2018.The sac growth was discovered on (b)(6) 2018 during a routine patient follow up.However on (b)(6) 2018, it was confirmed by the rep that the patient had a type 2 endoleak with a possible type 1a, along with sac growth.On (b)(6) 2018 a secondary procedure was performed.Physician did a aortic proximal extension placement.The patient was initially implanted with a bifurcated stent, a suprarenal extension and two (2) limb extensions to treat an abdominal aortic aneurysm back on (b)(6) 2015.No further information provided on patient condition post op.
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.A clinical assessment of the reported event could not be completed due to a lack of receipt of relevant medical records and/or imaging.Several attempts were made to obtain medical records and/or images but were denied.As such, event determination, off label conditions, related patient harms and patient disposition could not be independently assessed.No additional investigation of this reported event is planned.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.Corrections: common device name - update, model number - update, catalog number- remove, lot # - update, expiration date- update, udi # - update, device manufacture date - update.
Event or Problem Description
Updated information: a type 1a and type 2 endoleak was confirmed.A secondary procedure was completed and an other suprarenal extension was implanted to resolve the type 1a endoleak.The patient was reported as doing well.Another procedure was completed at a later date, the patient had coiling placed in the lumbar to resolve the type 2 endoleak.The patient was reported as doing good.

• Brand Name: AFX
• Common Device Name: VELA SUPRARENAL
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 7599130
• Report Number: 2031527-2018-00544
• Device Sequence Number: 178524
• Product Code: MIH
• UDI-Device Identifier: 00818009010049
• UDI-Public: (01)00818009010049(17)180131
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

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: 07/02/2015
• Device Model Number: A34-34/C100-O20 V
• Device Catalogue Number: F00765
• Device Lot Number: 1264649-012
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/16/2018
• Supplement Date Received by Manufacturer: 05/16/2018
• Initial Report FDA Received Date: 06/13/2018
• Supplement Report FDA Received Date: 02/07/2019
• 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: LIMB STENT GRAFT, LOT 1047169-008; LIMB STENT GRAFT, LOT 1252590005; VELA SUPRARENAL, LOT 1264649012
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR