MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number A34-34/C100-O20 V

Device Problems Off-Label Use (1494); Material Puncture/Hole (1504); Improper or Incorrect Procedure or Method (2017); Material Integrity Problem (2978); Unintended Movement (3026)

Patient Problems Aneurysm (1708); Death (1802); Failure of Implant (1924); Rupture (2208)

Event Date 02/28/2019

Event Type  Death  

Manufacturer Narrative

To date the incident sample has not been received for evaluation.If the sample is received or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.

Event 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 two (2) years post initial procedure, it was reported that the patient underwent an open repair and the device were explanted due to a possible type 3b endoleak, rupture, aaa enlargement, and migration of the stent graft.In review of the patient's 18 month follow-up a scan, a possible type 1a endoleak was noted.The proximal graft stent appeared to have migrated and lost of the seal was identified.No intervention was reported for this event.Approximately three (3) weeks post open repair, endologix was notified that the patient had expired.The date or cause of death was not reported.Additional information regarding this event has been requested.

Manufacturer Narrative

The manufacturing lot evaluation 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, clinical was able to find substantial evidence to support the following reported events of a 1a and 3b endoleaks and migration of the suprarenal stent graft extension, aaa growth, a rupture, an open conversion with explant and death.These events were most likely user related due to the off-label neck anatomy 40.5mm (ifu states neck diameter between 18-32mm).The final patient status was reported to be expired due to circulatory failure and cardiogenic shock.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.Device iteration is afx with duraply.Corrections: has been updated, outcomes attributed to adverse events has been updated, brand name has been updated, product description has been updated, common device name has been updated, model number, lot #, expiration date and unique identifier (udi) # has been updated, device manufacture date has been updated, device code: remove code 2978, result code: remove code 3221, conclusion code: remove code 11.

Event Description

Additional information: at the completion of the clinical assessment, clinical was able to find substantial evidence to support the following reported events of a 1a and 3b endoleaks and migration of the suprarenal stent graft extension, aaa growth, a rupture, an open conversion with explant and death.

• Brand Name: AFX
• Type of Device: VELA SUPRARENAL
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8450379
• MDR Text Key: 139794174
• Report Number: 2031527-2019-00141
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009014580
• UDI-Public: (01)00818009014580(17)170920
• Combination Product (y/n): N
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/28/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 11/16/2019
• Device Model Number: A34-34/C100-O20 V
• Device Lot Number: 1616776-015
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/28/2019
• Initial Date FDA Received: 03/25/2019
• Supplement Dates Manufacturer Received: 02/28/2019
• Supplement Dates FDA Received: 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0007-2019
• Patient Sequence Number: 1
• Treatment: AFX2 BIFURCATED STENT GRAFT, LOT 1592092R010.; SUPRARENAL STENT GRAFT EXTENSION, LOT 1616776015.
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 72 YR