MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number	A25-25/C95-O20 V
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017); Deformation Due to Compressive Stress (2889); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
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
The patient was initially implanted with a bifurcated stent graft, a stent graft extension and an infrarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately five (5) years post initial procedure, a type 1a endoleak was identified (exact date of event is unknown).It was reported that an intervention was completed with an non- endologix stent (medtronic).No further information was provided.As of the date of this report, there have been no additional patient sequelae reported.
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.At the completion of the clinical assessment, clinical was able to find substantial evidence to support the following events of a type 1a endoleak, migration of the suprarenal stent of 15mm, sac growth, type 2 endoleak, and partial collapse of the infrarenal stent.The 1a endoleak, migration of the suprarenal stent, sac growth and partial collapse of the infrarenal stent were most likely user related due to the off-label neck anatomy.The ir angle of 85 degrees should be less or equal to 60 degrees, as well as the short neck of 2-4mm should be equal to or greater than 15mm per the ifu.The type 2 endoleak is anatomy related and is a non-device related failure.No additional investigation of this reported event is planned however if additional information pertinent to the incident is obtained, a follow-up report will be submitted.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.Device iteration is afx with duraply.

• Brand Name: AFX
• Common Device Name: VELA SUPRARENAL
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8525447
• Report Number: 2031527-2019-00192
• Device Sequence Number: 14170393
• Product Code: MIH
• UDI-Device Identifier: 00818009013620
• UDI-Public: (01)00818009013620(17)150306
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2019

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: 03/06/2015
• Device Model Number: A25-25/C95-O20 V
• Device Lot Number: 1214253-005
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/22/2019
• Supplement Date Received by Manufacturer: 03/22/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 10/02/2019
• 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: BIFURCATED STENT GRAFT, LOT 1053205-004; VELA INFRARENAL, LOT 1164361001
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR