MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number	A34-34/C100-O20 V
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Aneurysm (1708); Death (1802); Failure of Implant (1924); Rupture (2208)
Date of Event	04/15/2017
Type of Reportable Event	Death
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 came in emergently with an abdominal aortic aneurysm.It was reported the patient had severe aortic neck angulation and due to the health of the patient, an open repair procedure was not an option.The physician elected to complete an endovascular repair procedure with the understanding of using the afx introducer sheaths and lunderquist wires as tools to straighten the aorta enough to implant the devices.In attempting to straighten the aorta the patient ruptured and became hypotensive.The physician was able to place an occlusive balloon followed by the bifurcated stent and two suprarenal aortic extensions.The physician was not able to successfully cover the aortic neck with the two proximal extensions and determined the angle required the placement of a third suprarenal device.During the implant of the third proximal extension the delivery system dislodged one of the suprarenal extensions out of the proximal end of the bifurcated stent.Due to the severity of the patient anatomy the physician aborted the completion of the initial implant procedure.It was reported the patient expired on (b)(6) 2017.
Additional Manufacturer Narrative
The review of manufacturing lot confirmed all devices met specifications prior to release.The device was not returned therefore no evaluation was completed.At the completion of the clinical assessment based on lack of medical information available, clinical was unable to find substantial evidence to support the intraoperative rupture, hypotension, and patient death.Clinical found evidence to reasonably suggest that off label use of neck anatomy contributed to the reported events.Clinical was unable to find evidence to reasonably suggest any additional contributing factor to the reported event due to limited available patient information.These types of events will be monitored and trended as part of the quality system.Correction: patient identifier.Patient code: remove (b)(4).

• Brand Name: AFX
• Common Device Name: VELA SUPRARENAL
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 6579992
• Report Number: 2031527-2017-00251
• Device Sequence Number: 953649
• Product Code: MIH
• UDI-Device Identifier: 00818009014214
• UDI-Public: (01)00818009014214(17)200131
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 04/19/2017

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: 11/22/2019
• Device Model Number: A34-34/C100-O20 V
• Device Lot Number: 1619323-014
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/20/2017
• Initial Date Received by Manufacturer: 04/19/2017
• Supplement Date Received by Manufacturer: 04/19/2017
• Initial Report FDA Received Date: 05/19/2017
• Supplement Report FDA Received Date: 07/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 81 YR