MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; INFRARENAL AORTO UNI-ILIAC

Model Number A34-34/C100

Device Problems Failure To Adhere Or Bond (1031); Collapse (1099); Hole In Material (1293); Leak/Splash (1354); Unintended Movement (3026)

Patient Problems Aneurysm (1708); Low Blood Pressure/ Hypotension (1914); Failure of Implant (1924); Renal Failure (2041)

Event Date 09/19/2016

Event Type  Injury  

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.Devices remain implanted in the patient.

Event Description

It was reported that the patient had an initial procedure on (b)(6) 2012 with a bifurcated stent, an infrarenal aortic extension, and three limb stent grafts.On follow up the physician identified movement of the proximal extension causing an endoleak.The patient has had no reported intervention at this time.The patient status is unknown.

Manufacturer Narrative

Clinical review found evidence to reasonably suggest the following factors contributed to the reported event: off-label usage, preexisting endoleak type ia at implant, pre-existing aortic dissection, increase in the infrarenal aortic angulation, and increased angulation of the left iliac limb at the bifurcation.The manufacturing evaluation did not reveal any issues or deviations that would explain the reported event.The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned, therefore no physical evaluation was completed.(b)(4).

• Brand Name: AFX
• Type of Device: INFRARENAL AORTO UNI-ILIAC
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• Manufacturer Contact: victor arellano ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 6042331
• MDR Text Key: 57914225
• Report Number: 2031527-2016-00486
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/19/2016

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: 08/31/2015
• Device Model Number: A34-34/C100
• Device Lot Number: 1026641-010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/19/2016
• Initial Date FDA Received: 10/19/2016
• Supplement Dates Manufacturer Received: 09/19/2016
• Supplement Dates FDA Received: 03/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BIFURCATED- (B)(4); LIMB EXTENSION- (B)(4); LIMB EXTENSION- (B)(4); LIMB EXTENSION- (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR