MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA25-80/I20-40
Medical Device Problem Codes	Leak/Splash (1354); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	10/18/2018
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 previously implanted with a two (2) bifurcated stent grafts, a suprarenal stent graft extension and a limb stent extension to treat an abdominal aortic aneurysm (aaa).Approximately three (3) years post implant, a routine follow-up ct revealed an enlarging aaa with no identifiable leak.The patient was relined with a non endologix device (gore excluder) on (b)(6) 2018.The patient was reported in good condition post-secondary procedure.
Additional Manufacturer Narrative
At the completion of the clinical evaluation and based on the information received, there was substantial evidence to support the following observation of an indeterminate endoleak.Event relatedness and procedure related harms cannot be determined.The final patient status was reported in good condition post the secondary procedure.Contributing factors include the following: device-related due to strata material; anatomy-related due to tortuosity of the right iliac artery and presence of patent lumbar and inferior mesenteric arteries; and user-related due to the off-label conical neck.The manufacturing lot review confirmed all devices met specifications prior to release.These types of events will be monitored and trended as part of the quality system.Device code - remove 1354, result code - remove 3233, conclusion code - remove 11.
Event or Problem Description
Additional information received per clinical assessment confirming that an endoleak (at an indeterminate origin) was also present at the time of the reported event.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8100046
• Report Number: 2031527-2018-00888
• Device Sequence Number: 2418798
• Product Code: MIH
• UDI-Device Identifier: 00818009012210
• UDI-Public: (01)00818009012210(17)181214
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2018

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: 12/14/2018
• Device Model Number: BA25-80/I20-40
• Device Catalogue Number: BA25-80/I20-40
• Device Lot Number: 1283314-017
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/24/2018
• Supplement Date Received by Manufacturer: 10/24/2018
• Initial Report FDA Received Date: 11/23/2018
• Supplement Report FDA Received Date: 02/22/2019
• 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: AFX-BIFURCATED STENT GRAFT:1283113-013; AFX-LIMB STENT GRAFT:1389181-012; AFX-VELA SUPRARENAL:1252489--031
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR