MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number	A28-28/C95-O20V
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aneurysm (1708); Death (1802); Rupture (2208)
Date of Event	05/15/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device involved in this event will not be returned for evaluation as it remains implanted in the patient.Patient medical records and imaging studies will be requested for further evaluation by the clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Device iteration is afx with duraply.Device remains implanted.
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft and a suprarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately 3.5 years post initial procedure, a type 1 (origin unknown) endoleak was reported.Patient was admitted and intervention was not recommended due to patient's poor health condition.The patient elected palliative care.The patient expired on (b)(6) 2019.
Additional Manufacturer Narrative
Clinical assessment was completed based on the received medical records.The type ia endoleak, sac enlargement (amount not specified), rupture and death complaints are confirmed.The patient was not an interventional or surgical candidate due to poor overall health and was sent home with palliative care and ultimately passed away.Procedure related harms, device, user, procedure or anatomy relatedness of this complaint could not be determined.The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned as the device remains implanted therefore no evaluation was completed.No additional investigation of this reported event is planned however if additional information pertinent to the incident is obtained, a follow-up report will be submitted.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.
Additional Manufacturer Narrative
Clinical assessment was completed based on the received medical records.The type ia endoleak, sac enlargement (amount not specified), rupture and death complaints are confirmed.The patient was not an interventional or surgical candidate due to poor overall health and was sent home with palliative care and ultimately passed away.Procedure related harms, device, user, procedure or anatomy relatedness of this complaint could not be determined.The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned as the device remains implanted therefore no evaluation was completed.No additional investigation of this reported event is planned however if additional information pertinent to the incident is obtained, a follow-up report will be submitted.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.Corrections: d2: product description - updated; d4: model #/lot #/expiration date/udi # - updated; d11: concomitant medical devices - updated; h4: manufacturer date - updated; h6: result code: remove code 3233; h6: conclusion code: remove code 11.

• Brand Name: AFX
• Common Device Name: VELA SUPRARENAL
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 9511886
• Report Number: 2031527-2019-00621
• Device Sequence Number: 14198479
• Product Code: MIH
• UDI-Device Identifier: 00818009010032
• UDI-Public: (01)00818009010032(17)171126
• Combination Product (Y/N): N
• Initial Reporter State: AL
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/04/2019

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: 08/04/2015
• Device Model Number: A28-28/C95-O20V
• Device Lot Number: 1272455002
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/04/2019
• Supplement Date Received by Manufacturer: 12/04/2019; 12/04/2019
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 05/04/2020; 05/07/2020
• 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 BIFURCATED STENT GRAFT (LN 1290517-011).; AFX BIFURCATED STENT GRAFT (LN 1290517-011).; VELA SUPRARENAL, LOT 1272455002.; VELA SUPRARENAL, LOT 1272455002
• Outcome Attributed to Adverse Event: Death
• Patient Age: 87 YR