MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA28-60/I16-40
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Detachment Of Device Component (1104); Leak/Splash (1354); Patient-Device Incompatibility (2682); Delamination (2904)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	08/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in the event will not be returned for evaluation, they remain implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
The patient was initially implanted with a bifurcated stent, an infrarenal aortic extension and a limb extension.The patient came in for a routine follow up which showed the patient had a type 3a endoleak with component separation of the iliac limb and the main body.The patient is also reported to have aneurysm sac growth.The physician elected to implant two additional limb extensions to seal the endoleak.A final patient status was not originally reported to endologix.To date there have been no additional adverse events reported for this patient.
Additional Manufacturer Narrative
Based on the information available the root cause of the reported event is unknown.Device was not returned and therefore sample evaluation was not able to confirm the reported events.
Additional Manufacturer Narrative
Based on the information received, clinical evaluation confirmed the reported type iiia endoleak with complete iliac component separation, aneurysm sac growth, secondary reline procedure, and patient in stable condition.The most likely cause of the distal loss of seal and implant separation of the iliac limb stent was an off-label iliac anatomy in combination with tortuous aorta-iliac anatomy (cautionary product use).The procedure-related harms included an open repair of access site (femoral artery repair) at the secondary repair procedure.The patient was discharged home in stable condition on the second post-operative day.The review of manufacturing lot confirmed all devices met specifications prior to release.The devices remain implanted in the patient and will not be returned; therefore, a device evaluation will not be completed.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 6742503
• Report Number: 2031527-2017-00476
• Device Sequence Number: 16366663
• Product Code: MIH
• UDI-Device Identifier: 00818009010216
• UDI-Public: (01)00818009010216(17)180119
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/23/2017

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: 01/19/2018
• Device Model Number: BA28-60/I16-40
• Device Lot Number: 1285641-025
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/23/2017
• Supplement Date Received by Manufacturer: 08/23/2017; 01/17/2018
• Initial Report FDA Received Date: 07/25/2017
• Supplement Report FDA Received Date: 07/25/2017; 05/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR