MAUDE Adverse Event Report: ENDOLOGIX, INC. AFX2; AFX2 BIFURCATED STENT GRAFT

Model Number	BEA25-110/I16-30
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Leak/Splash (1354)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/16/2017
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, the patient was initially implanted with a bifurcated stent and a suprarenal extension.On the one month routine follow up ct, a type 1b endoleak with sac growth was discovered.The physician elected to use a non- endologix stent graft to resolve this reported event.The patient was reported as doing well and no additional patient sequelae have been reported.
Additional Manufacturer Narrative
The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned therefore no evaluation was completed.At the completion of the clinical assessment, clinical was able to find substantial evidence to support the following reported events of type 1b endoleak at the distal and a non- endologix iliac limb extensions stent implanted at the distal.Clinical was also able to find substantial evidence to support the following additional event of an indeterminate endoleak at the proximal discovered 2 months post implant on (b)(6) 2017.The most likely cause of the distal loss of seal was related to the off-label concomitant use of non-endologix stents as distal iliac limb extensions and also the proximal left common iliac artery aneurysm likely contributed to the event.The associated clinical harms for this event included: type ib endoleak.The most likely cause of the proximal seal could not be determined.The off label neck length and oversized (off-label) proximal cuff in conjunction with the irregular calcifications (cautionary product use condition) in the proximal neck likely contributed to the indeterminate endoleak (possible type ia endoleak).However, there was a lumbar artery at the level fabric start that may also be the source of an endoleak.The associated clinical harms for this event included: indeterminate endoleak.The final patient disposition was reported to be in good condition, 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: AFX2
• Common Device Name: AFX2 BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7034143
• Report Number: 2031527-2017-00604
• Device Sequence Number: 16379765
• Product Code: MIH
• UDI-Device Identifier: 00818009014856
• UDI-Public: (01)00818009014856(17)180713
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2017

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: 07/13/2018
• Device Model Number: BEA25-110/I16-30
• Device Lot Number: 1720822-002
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/16/2017
• Supplement Date Received by Manufacturer: 10/16/2017
• Initial Report FDA Received Date: 11/15/2017
• Supplement Report FDA Received Date: 01/17/2018
• 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: VELA SUPRARENAL EXTENSION, LOT # 1720421-025
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR