MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA25-90/I16-30
Medical Device Problem Codes	Leak/Splash (1354); Material Integrity Problem (2978)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/21/2018
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
Patient was initially implanted with an afx bifurcated, one vela suprarenal, and one ovation limb.Recently, it was noted that the patient has a possible endoleak type iiib with fabric billowing/tear.Patient is currently being monitored, there has not been any plans for intervention.As of this report, there has not been any additional patient sequelae reported.
Additional Manufacturer Narrative
At the completion of the clinical assessment, clinical was able to refute the reported event of a type 3b endoleak, rather there is the fabric billowing in the acceptable range.No device malfunction noted therefore this is no longer a reportable event.
Event or Problem Description
At the completion of the clinical assessment, clinical was able to refute the reported event of a type 3b endoleak, rather there is the fabric billowing in the acceptable range.No device malfunction noted therefore this is no longer a reportable event.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 7887201
• Report Number: 2031527-2018-00724
• Device Sequence Number: 228708
• Product Code: MIH
• UDI-Device Identifier: 00818009010230
• UDI-Public: (01)00818009010230(17)180212
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 08/21/2018

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: 02/02/2018
• Device Model Number: BA25-90/I16-30
• Device Lot Number: 1252264018
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/21/2018
• Supplement Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 09/18/2018
• Supplement Report FDA Received Date: 11/14/2018
• 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: AFX VELA SUPRARENAL-LOT: 1472813003; AFX2-BIFURCATED-LOT: 1625372002; OVATION-LIMB-LOT: FS042016-20
• Outcome Attributed to Adverse Event: Other