MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; BIFURCATED STENT GRAFT

Model Number	BA22-90/I16-30
Medical Device Problem Codes	Hole In Material (1293); Leak/Splash (1354); Material Integrity Problem (2978)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/18/2017
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
On (b)(6) 2017, an evar was performed for a patient with abdominal aortic aneurysm.A bifurcated stent and proximal extension were implanted.An angiography was performed and it showed an endoleak from the distal portion (right side) of bifurcated stent.The physician elected to reline the bifurcated stent area with another proximal extension.Another angiography showed that the endoleak has decreased but did not completely disappear.On (b)(6) 2017, during a follow up, it was reported that a ct showed that the endoleak had disappeared and the aneurysm size had decreased.The patient is currently being monitored and 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 reported event of a type iiib endoleak of the main body (intra-operative).The most likely cause of the compromised stent graft integrity of the main body could not be determined due to lack of medical information during the implant.Procedure related harms included intra-operative type iiib endoleak, which was treated by placing an additional infrarenal cuff but was unable to resolve the endoleak.The patient was under surveillance.Reportedly, the endoleak disappeared post one month of the implant.To date there has been no reports of further negative patient sequelae.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.These types of events will be monitored and trended as part of the quality system.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7183856
• Report Number: 2031527-2018-00025
• Device Sequence Number: 16401025
• Product Code: MIH
• UDI-Device Identifier: 00818009010223
• UDI-Public: (01)00818009010223(17)200508
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2017

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: 05/08/2020
• Device Model Number: BA22-90/I16-30
• Device Lot Number: 1683596-023
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/21/2017
• Supplement Date Received by Manufacturer: 12/21/2017
• Initial Report FDA Received Date: 01/11/2018
• Supplement Report FDA Received Date: 03/21/2018
• 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: PROXIMAL EXTENSION, LOT # 1679659-022; PROXIMAL EXTENSION, LOT # 1727648-020
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR