MAUDE Adverse Event Report: ENDOLOGIX, INC. AFX; BIFURCATED

Model Number BA28-90/I20-30

Device Problems Failure To Adhere Or Bond (1031); Material Rupture (1546); Stretched (1601)

Patient Problems Low Blood Pressure/ Hypotension (1914); Hypovolemic Shock (1917); Failure of Implant (1924); Pain (1994); Renal Failure (2041); Rupture (2208); Respiratory Failure (2484)

Event Date 10/19/2015

Event Type  Injury  

Manufacturer Narrative

The device involved in the event will not be returned for evaluation as it remains implanted in the patient.If additional info pertinent to the incident is obtained, a follow-up report will be submitted.

Event Description

It was reported the patient had a procedure on (b)(6) 2014.Reportedly, the patient was admitted to the hospital with low blood pressure and back pain as a result of a rupture.Consequently, the physician elected to explant the device.No complications were reported with the patient as a result of the event.

Manufacturer Narrative

Based upon the clinical assessment, the reported type iiib endoleak was inconclusive.The manufacturing record review did not reveal any issues or deviations that would explain the reported event.Based upon the investigation, a design or manufacturing root cause was not identified.The clinical review identified possible factors that may have contributed to the patient outcome: product use was incongruent with the ifu due to: the presence of a juxtarenal aneurysm (snorkel procedure); aortic diameter greater than 32 mm; aortic neck length less than 15 mm; left common iliac angulation of greater than 90°; bilateral inadequate access morphology; and, an infrarenal angulation greater than 60°.Of these conditions, the tortuosity of the aorta and the iliac artery most likely contributed to this complaint.Cautionary product use conditions that might have contributed to this event included: the calcifications at the bifurcation and iliac arteries.Patient factors that might have contributed to this event included antiplatelet therapy.

• Brand Name: AFX
• Type of Device: BIFURCATED
• Manufacturer (Section D): ENDOLOGIX, INC.; irvine CA 92618
• Manufacturer Contact: henry to ; 2 musick; irvine, CA 92618 ; 8009832284
• MDR Report Key: 5235466
• MDR Text Key: 31637632
• Report Number: 2031527-2015-00450
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Model Number: BA28-90/I20-30
• Device Lot Number: 1101200-001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/19/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/30/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR