MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number	A28-28/C75-O20V
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Death (1802); Failure of Implant (1924); Occlusion (1984); Heart Failure (2206)
Date of Event	03/25/2019
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 afx2 abdominal aortic aneurysm stent.Immediately post initial case, an angiogram and ct revealed a type ia and type ii endoleaks.The physician then made several unsuccessful attempts to resolve the leaks, but ultimately decided to terminate the procedure and monitor the patient, who also had a heart attack after the case.Four (4) days post initial treatment, the patient passed away from cardiac complications.The physician commented that the patient had severe cardiac problems prior to the aaa intervention with several coronary stents implanted.In addition, after the patient's heart attack, the coronary stents became partially occluded, after which the patient's condition continued to worsen even with attempts to treat.
Additional Manufacturer Narrative
At the completion of the clinical evaluation and based on the information received, there was unsubstantial evidence to support the reported event of an intraoperative type ia endoleak, heart attack, and death due to a lack of relevant medical records and images.The device, user, procedure, or anatomy relatedness of this event could not be determined; contributing factors for the reported type ia endoleak is most likely the off-label neck angle 170° (ifu states less than 60°).The procedure-related harms identified were a type ii endoleak from the lumbar artery.The final patient status was reported to be expired four days post the implant procedure most likely due to the pre-existing heart conditions.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 iteration is afx with duraply.

• Brand Name: AFX
• Common Device Name: VELA SUPRARENAL
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8501428
• Report Number: 2031527-2019-00181
• Device Sequence Number: 1884757
• Product Code: MIH
• UDI-Device Identifier: 00818009014740
• UDI-Public: (01)00818009014740(17)191003
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2019

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: 02/07/2022
• Device Model Number: A28-28/C75-O20V
• Device Lot Number: 2058935-008
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/25/2019
• Supplement Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 04/10/2019
• Supplement Report FDA Received Date: 06/18/2019
• 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-VELA SUPRARENAL:2058935-008; AFX2 BIFURCATED STENT GRAFT: 1993838-005; AFX-VELA SUPRARENAL: 2058935-008
• Outcome Attributed to Adverse Event: Death