MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA28-120/I20-40
Medical Device Problem Codes	Leak/Splash (1354); Material Separation (1562)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot history records related to the subject device referenced in this complaint record were reviewed for potential contributing factors for the failure mode(s) described in this event.A review of the device quality records showed that the device(s) demonstrated compliance to established procedures and specifications at the time of manufacture.
Event or Problem Description
The patient was initially implanted with an afx device to treat an aneurysm.Approximately 3 years later the patient was presented with a potential endoleak due to separation of the iliac limb from the afx main body.A reintervention is planned for a later date to treat the endoleak.As of the date of this report there have been no additional patient sequelae reported.
Event or Problem Description
A reintervention was completed to place an additional infrarenal cuff successfully resolving the leak.As of the date of this report there have been no additional patient sequelae reported.
Additional Manufacturer Narrative
The root cause for the reported type iiia endoleak could not be determined with the limited information available.An evaluation of the reported event could not be completed due to a lack of receipt of relevant medical records and/or imaging.Requests were made on (b)(6) 2018 and (b)(6) 2018, and an inadequate response was received.As such, event determination, off label conditions, related patient harms and patient disposition could not be independently assessed.A re-intervention was completed to place an additional infrarenal cuff successfully resolving the endoleak.The lot history records related to the subject device referenced in this complaint record were reviewed for potential contributing factors for the failure mode(s) described in this event.A review of the device quality records showed that the device(s) demonstrated compliance to established procedures and specifications at the time of manufacture.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 7987270
• Report Number: 2031527-2018-00792
• Device Sequence Number: 1706434
• Product Code: MIH
• UDI-Device Identifier: 00818009011992
• UDI-Public: (01)00818009011992
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2018

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: 04/22/2018
• Device Model Number: BA28-120/I20-40
• Device Catalogue Number: BA28-120/I20-40
• Device Lot Number: 1331260008
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/19/2018
• Supplement Date Received by Manufacturer: 09/19/2018
• Initial Report FDA Received Date: 10/19/2018
• Supplement Report FDA Received Date: 12/13/2018
• 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: INFRARENAL AORTIC EXTENSION-1264693-007; INFRARENAL AORTIC EXTENSION-1267818008; VELA SUPRARENAL-1252485044
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 75 YR