MAUDE Adverse Event Report: ENDOLOGIX AFX2; AFX2 BIFURCATED STENT GRAFT

Model Number	BEA25-80/I20-40
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/23/2018
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
The patient was initially implanted with an afx2 bifurcated stent graft.A possible type ii or iiia endoleak was discovered.The physician performed an angiogram but was not able to confirm the endoleak.The physician elected to perform secondary procedure.Upon completion of the secondary procedure an angiogram was performed where an oblique angle type ii endoleak was identified.There has been no additional patient sequelae reported at this time.
Additional Manufacturer Narrative
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 and denied response were received.As such, event determination, off label conditions, related patient harms and patient disposition could not be independently assessed.The review of manufacturing lot confirmed all devices met specifications prior to release.No additional investigations of this reported complaint are planned.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.

• Brand Name: AFX2
• Common Device Name: AFX2 BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 7799686
• Report Number: 2031527-2018-00670
• Device Sequence Number: 18878531
• Product Code: MIH
• UDI-Device Identifier: 00818009014689
• UDI-Public: (01)00818009014689(17)170831
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2018

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: 08/31/2017
• Device Model Number: BEA25-80/I20-40
• Device Lot Number: 1585766-008
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/24/2018
• Supplement Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 08/20/2018
• Supplement Report FDA Received Date: 03/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0007-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX- VELA INFRARENAL-LOT-1588910-007; AFX- VELA SUPRARENAL-LOT-1472853-021
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR