MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; PROXIMAL EXTENSION

Model Number	A25-25/C75
Medical Device Problem Codes	Leak/Splash (1354); Unintended Movement (3026)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/13/2018
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) 2018 a bifurcated stent graft and proximal extension were implanted to treat an abdominal aortic aneurysm.Upon deployment and balloon touch up of an afx proximal extension, an angiogram showed a type ia endoleak due to the proximal extension moving slightly distally into the aneurysm sac.Physician elected to implanted a second proximal extension, however, the type ia endoleak persisted.The procedure was concluded and the patient is to being monitored.
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, due to the lack of relevant medical imaging or records, clinical was unable to find substantial evidence to support the following reported event of stent movement and type 1a endoleak.The most likely cause of the persistent proximal loss of seal was the off-label neck anatomy.Reportedly, the patient will be on surveillance.To date there has been no reports of further negative patient sequalae.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.

• Brand Name: AFX
• Common Device Name: PROXIMAL EXTENSION
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7429204
• Report Number: 2031527-2018-00322
• Device Sequence Number: 1718315
• Product Code: MIH
• UDI-Device Identifier: 00818009010285
• UDI-Public: (01)00818009010285(17)180804
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2018

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: Health Professional
• Device Expiration Date: 08/04/2018
• Device Model Number: A25-25/C75
• Device Lot Number: 1352191-040
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/15/2018
• Supplement Date Received by Manufacturer: 03/15/2018
• Initial Report FDA Received Date: 04/13/2018
• Supplement Report FDA Received Date: 06/13/2018
• 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: BIFURCATED STENT GRAFT, LOT # 1759744-003; PROXIMAL EXTENSION, LOT # 1737485-005; BIFURCATED STENT GRAFT, LOT # 1759744-003; PROXIMAL EXTENSION, LOT # 1737485-005
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR