MAUDE Adverse Event Report: ENDOLOGIX, INC. AFX

Model Number BA28-100/I16-40

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

Patient Problems Hemorrhage/Bleeding (1888); Failure of Implant (1924); Test Result (2695)

Event Date 06/21/2015

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 that on (b)(6) 2012 the patient had a bifurcated aortic extension implanted.Reportedly, the patient presented emergently on (b)(6) 82015 symptomatic.A computed tomography was done and showed a proximal endoleak.The physician elected to reline with a cook renu graft, and did a fem by fem bypass.However, the computed tomography's were reviewed and it might be an endoleak 3b due to dye coming from the bifurcation.Patient is intubated, but in stable condition.

Manufacturer Narrative

Based upon the investigation findings, the reported event is inconclusive.The implant remains in the pt.A clinical assessment could not be completed due to lack of info.A mfg record review was performed and the lot met all release criteria with no issues or deviations that would explain the reported event.A design or mfg root cause for the reported event could not be identified based on the available info, and overall, the investigation is inconclusive.

• Brand Name: AFX
• Manufacturer (Section D): ENDOLOGIX, INC.; irvine CA 92618
• Manufacturer Contact: henry to ; 2 musick; irvine, CA 92618 ; 8009832284
• MDR Report Key: 5194441
• MDR Text Key: 30216165
• Report Number: 2031527-2015-00428
• 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: 06/22/2015

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2012
• Device Model Number: BA28-100/I16-40
• Device Lot Number: W11-5020-010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2015
• Initial Date FDA Received: 10/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/29/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2011
• 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