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

Model Number	IS20-25/C55 SA
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Leak/Splash (1354)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	12/12/2017
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) 2016, the patient was initially implanted with a bifurcated stent, a suprarenal extension and a limb stent graft.On (b)(6) 2017, during a routine follow up, sac growth with a possible 1b endoleak was discovered.On (b)(6) 2017, the physician elected to implant another limb stent graft to seal the leak.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 events of a type 1b endoleak of the left common iliac artery and a secondary endovascular procedure.The most likely cause of the distal loss of seal was the placement of stent in the short iliac anatomy but the anatomy is not considered off-label.Patient was discharged home in stable condition on the same post-operative day.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: LIMB STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7167683
• Report Number: 2031527-2018-00021
• Device Sequence Number: 16486978
• Product Code: MIH
• UDI-Device Identifier: 00818009011466
• UDI-Public: (01)00818009011466(17)180630
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2017

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: 06/30/2018
• Device Model Number: IS20-25/C55 SA
• Device Lot Number: 1253185-023
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/14/2017
• Supplement Date Received by Manufacturer: 12/14/2017
• Initial Report FDA Received Date: 01/05/2018
• Supplement Report FDA Received Date: 04/04/2018
• 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, LOT # 1283305-027; SUPRARENAL EXTENSION, LOT # 1286549-008
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR