MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; LIMB

Model Number I20-13/C88F SA

Device Problems Failure To Adhere Or Bond (1031); Leak/Splash (1354)

Patient Problems Aneurysm (1708); Death (1802); Hypovolemic Shock (1917); Failure of Implant (1924); Renal Failure (2041); Rupture (2208); Respiratory Failure (2484)

Event Date 12/02/2016

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.Devices have not been returned.

Event Description

Patient initially implanted with a bifurcated stent, a suprarenal aortic extension, and a limb extension on (b)(6) 2015.The patient came in emergently with a rupture, there was a bilateral iliac rupture connected to the abdominal rupture.The physician identified bilateral type 1b endoleaks.The physician elected to implant 3 ovation limb extensions to seal the endoleak.The procedure was completed and computed tomography (ct) scan did not show any leaks.The patient was treated for blood loss and the retroperitoneal space was evacuated.Following the procedure the patient transferred to the intensive care unit.On (b)(6) 2016 the patient was reported to be in renal failure and receiving hydration, patient was also on ventilation.On (b)(6) 2016 the patient expired due to multiple organ failure.

Manufacturer Narrative

At the completion of the complaint investigation, based on the information received, the clinical evaluation was able to confirm the reported bilateral type 1b endoleaks, rupture, acute renal failure, acute blood loss and multiple organ failure.The clinical assessment also identified a type 2 endoleak at 17 months post implant.The clinical evaluation additionally found evidence to reasonably suggest the following contributing factors to the reported event; off label use, patient anatomy and calcified iliac landing zones.The complications of the rupture, massive blood loss, shock and multiple organ failure post-endovascular repair coupled with preexisting comorbidities most likely contributed to the patient's demise seven days post endovascular repair.The review of manufacturing lot confirmed all devices met specifications prior to release.The event devices have not been returned and were not available for further evaluation.The root cause of the reported event is unknown.There is not enough information to determine the root cause of the reported event at this time.

• Brand Name: AFX
• Type of Device: LIMB
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• Manufacturer Contact: tahereh sedighi ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 6216909
• MDR Text Key: 63686957
• Report Number: 2031527-2016-00604
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/27/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Model Number: I20-13/C88F SA
• Device Lot Number: 1047364-003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2016
• Initial Date FDA Received: 12/31/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2013
• 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: AORTO UNI-ILIAC [SUPRARENAL]- (B)(4); BIFURCATED- (B)(4)
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 79 YR