MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; VELA SUPRARENAL

Model Number	A34-34/C80-O20 V
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Leak/Splash (1354); Off-Label Use (1494); Material Puncture/Hole (1504); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); No Information (3190)
Date of Event	12/02/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation and remain implanted in the patient.If additional information is obtained at a later time that is pertinent to this event, a follow-up report will then be submitted.
Event or Problem Description
The patient was implanted with an afx bifurcated stent graft and vela suprarenal on 13 jan 2015.The secondary case for this patient was completed on 05 jan 2016 for an unknown reason and the patient was implanted with an afx vela suprarenal.
Additional Manufacturer Narrative
At the completion of the clinical evaluation, based on the information received there were substantial evidence to support the following reported events; a secondary procedure.Additional findings include an endoleak type 1a of the suprarenal cuff.Device, user, procedure or anatomy relatedness of this complaint could not be determined based on the information shared with endologix to review.Procedure related harms for this complaint could not be determined based on the information shared with endologix to review.The final patient status was not reported.The review of manufacturing lot confirmed all devices met specifications prior to release.Devices remain implanted in the patient and were not returned, no evaluation completed.This complaint is not capa eligible at this time.These types of events will be monitored and trended as part of the quality system.Suspect medical device changed to vela suprarenal.
Additional Manufacturer Narrative
Based on the information received, clinical evaluation confirmed the reported secondary endovascular procedure.Additionally, clinical assessment determined that there was evidence to reasonable suggest intra-operative type ia endoleak, bare metal stent implanted to resolve the proximal loss of seal, occurred that was not included in the event as reported and discovered during the review of the implant procedure angiogram.Clinical assessment also determined that there was evidence to reasonable suggest a post-operative type ia endoleak, occurred that was not included in the event as reported.The proximal loss of seal was discovered during the review of the 12 month post the implant angiogram.The root cause for the type 1a endoleaks is most likely user related (off-label neck anatomy and concomitant use of the product outside the ifu).Procedure related harms for this complaint could not be determined based on the information shared with endologix to review.The final patient status was not reported.Devices remain implanted in the patient and were not returned, no evaluation completed.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.Serial number removed - correction.Lot number - correction.Device manufacturer date - correction.

• Brand Name: AFX
• Common Device Name: VELA SUPRARENAL
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7444255
• Report Number: 2031527-2018-00352
• Device Sequence Number: 1147285
• Product Code: MIH
• UDI-Device Identifier: 00818009010025
• UDI-Public: (01)00818009010025(17)170626
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/13/2018

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: 05/19/2014
• Device Model Number: A34-34/C80-O20 V
• Device Lot Number: 1246590025
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/02/2015
• Supplement Date Received by Manufacturer: 12/02/2015; 05/30/2018
• Initial Report FDA Received Date: 04/19/2018
• Supplement Report FDA Received Date: 07/09/2018; 02/06/2019
• 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-BIFURCATED STENT GRAFT - LOT 1251775-057; AFX-VELA SUPRARENAL - LOT 1246590-025; AFX-BIFURCATED STENT GRAFT - LOT 1251775-057; AFX-VELA SUPRARENAL - LOT 1246590-025
• Outcome Attributed to Adverse Event: Required Intervention