MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA28-70/I16-30
Medical Device Problem Codes	Off-Label Use (1494); Material Puncture/Hole (1504); Product Quality Problem (1506); Improper or Incorrect Procedure or Method (2017); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Failure of Implant (1924); Rupture (2208)
Date of Event	03/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned for evaluation.A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
The patient was initially implanted with an afx bifurcated stent graft, a vela suprarenal stent graft extension, and a vela infarenal stent graft extension to treat an abdominal aortic aneurysm.Approximately four (4) years post initial implant the patient presented with a rupture and possible iiib endoleak.The physician performed a secondary procedure where the patient was relined with a non-endologix device.The patient was discharged from the hospital post-secondary procedure and is reported as doing excellent.No further additional information or patient sequalae has been reported at this time.
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 evaluation and based on the information received, there was substantial evidence to support the following reported events: a ruptured abdominal aortic aneurysm (aaa) and a type iiib endoleak of the bifurcated device.Clinical assessment also determined that there was evidence to reasonably suggest the following occurred which were not included in the event as reported: non-endologix stents implanted bilaterally in the common iliac artery (lcia) prior to (b)(6) 2016 (off-label use); occlusion of a non-endologix stent in the lcia with additional endovascular procedure performed on (b)(6) 2016; non-endologix stent implanted in the superior mesenteric artery on (b)(6) 2019; intramural thrombus observed on (b)(6) 2019 per ct.These additional findings were discovered during review on 17 may 2019.The event is most likely user-related due to the non-endologix stent placement (leak was observed at the bifurcation of the afx device and at the superior stent margin of the non-endologix device), and the extra manipulation of the two (2) additional endovascular procedures.Procedure-related harms for this event could not be determined.The final patient status was reported as being stable.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.
Event or Problem Description
Additional information received per clinical assessment confirming the following: a non-endologix stents in bilateral common iliac artery: unknown date of implant- off label condition, a non-endologix stent occlusion in lcia: 16month post the initial implant (additional endovascular procedure was performed on (b)(6) 2016 to treat the occlusion of the non -endologix stent) a non-endologix stent in the superior mesenteric artery: 44month post implant (additional endovascular procedure was performed on (b)(6) 2019).

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8476204
• Report Number: 2031527-2019-00155
• Device Sequence Number: 13821510
• Product Code: MIH
• UDI-Device Identifier: 00818009010117
• UDI-Public: (01)00818009010117(17)170917
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,health
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2019

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: 09/17/2017
• Device Model Number: BA28-70/I16-30
• Device Lot Number: 1275836003
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 03/04/2019
• Initial Report FDA Received Date: 04/02/2019
• Supplement Report FDA Received Date: 09/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0006-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VELA INFRARENAL(LN 1252530023); VELA SUPRARENAL(LN 1287910003)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 71 YR