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

Model Number	BA28-70/I16-30
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Leak/Splash (1354)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/19/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in the event will not be returned for evaluation as it remains 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 or Problem Description
It was reported the patient had an initial procedure on (b)(6) 2016 with a bifurcated device.After the case, the angiogram looked great with no leaks.The patient had complications post procedure and had to be revived.The patient was returned to stable condition.A follow-up computed tomography done on (b)(6) 2016 revealed a type 1a endoleak.An attempt was made to try to repair the leak using a non-endologix stent.That was not successful, so two different non-endologix stents were used, along with a renal snorkel, to resolve the issue.

• Brand Name: AFX
• Common Device Name: BIFURCATED
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 5733885
• Report Number: 2031527-2016-00298
• Device Sequence Number: 465678
• Product Code: MIH
• UDI-Device Identifier: 00818009010117
• UDI-Public: (01)00818009010117(17)170714
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: PO40002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/19/2016

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/14/2017
• Device Model Number: BA28-70/I16-30
• Device Lot Number: 1264285-003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2016
• Initial Report FDA Received Date: 06/17/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR