MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA25-110/I16-30
Medical Device Problem Codes	Material Puncture/Hole (1504); Product Quality Problem (1506); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Death (1802); Failure of Implant (1924); Rupture (2208)
Date of Event	04/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation and remain implanted in the patient.If additional information is obtained at a later time that is pertinent to this event, a follow-up report will then be submitted.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the afx abdominal aortic aneurysm stent.Approximately three (3) years post initial procedure, the patient presented emergently with a ruptured aaa.The ct scan revealed a type iiia endoleak and a potential iiib endoleak.The patient was transferred to another hospital for treatment but expired in transit.
Additional Manufacturer Narrative
A clinical 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 for medical records, and no response was received for medical imaging.As such, event determination, off-label conditions, related patient harms, and patient disposition could not be independently assessed.The manufacturing lot review confirmed all devices met specifications prior to release.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.Device iteration is afx with duraply.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8584703
• Report Number: 2031527-2019-00222
• Device Sequence Number: 14210617
• Product Code: MIH
• UDI-Device Identifier: 00818009012180
• UDI-Public: (01)00818009012180(17)19111
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2019

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: 01/11/2019
• Device Model Number: BA25-110/I16-30
• Device Lot Number: 1414301-001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 04/23/2019
• Initial Report FDA Received Date: 05/06/2019
• Supplement Report FDA Received Date: 07/10/2019
• 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-0006-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX-LIMB STENT GRAFT:1253156-020; AFX-LIMB STENT GRAFT:1350053-006; AFX-VELA SUPRARENAL:1286549-038
• Outcome Attributed to Adverse Event: Death
• Patient Age: 58 YR