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

Model Number	A34-34/C100V
Medical Device Problem Codes	Material Puncture/Hole (1504); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	12/07/2016
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 infrarenal on (b)(6) 2014.On a later date, the patient was identified to have developed sac growth per angiogram irregularities noted at the bifurcation with no definitive endoleak.The secondary case for this patient was completed on (b)(6) 2016 and the physician relined the patient by implanting an afx2 bifurcated stent graft and two (2) vela suprarenals.
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,sac growth.The no definitive endoleak is refuted rather, there was a type iiib of the infra renal cuff.The complaint is most likely device related (strata material).Procedure related harms for this complaint could not be determined based on the information shared with endologix to review.The final patient status was stable with good results.The manufacturing lot evaluation confirmed all devices met specifications prior to release.The manufacturing record review did not reveal any issues or deviations that would explain the reported event.The lot usage history shows that no other units from the affected lots have been involved in any similar complaints at this time.The device was not returned as the device remains implanted therefore no evaluation was completed.A root cause investigation was carried out for all afx complaints having an identified failure mode of a type iiib endoleak.Endologix implemented the following corrective actions with the intent of reducing type iiib endoleak events; upgraded graft material (i.E.Duraply) and updates to the ifu and additional physician training.The change to duraply graft material and the ifu changes were put in place july 2014.The type iiib endoleak rate for afx manufactured and implanted before these corrective actions were put in place is trending at (b)(4).Since the corrective actions were implemented, the type iiib endoleak events reported for afx devices has been reduced to (b)(4).Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.Correction: suspect medical device is vela infrarenal new codes used: (list of new codes).Method codes 4109 historical data analysis, 4112 analysis of data provided by user/third party.Conclusions code 4315 cause not established.

• Brand Name: AFX
• Common Device Name: VELA INFRARENAL
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7445613
• Report Number: 2031527-2018-00269
• Device Sequence Number: 1511181
• Product Code: MIH
• UDI-Device Identifier: 00818009010247
• UDI-Public: (01)00818009010247(17)170730
• 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: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2018

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: 04/21/2015
• Device Model Number: A34-34/C100V
• Device Lot Number: 1178447002
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/07/2016
• Supplement Date Received by Manufacturer: 06/20/2018
• Initial Report FDA Received Date: 04/19/2018
• Supplement Report FDA Received Date: 08/17/2018
• 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 1265980020.; AFX-VELA INFRARENAL - LOT 1178447002.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR