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

Model Number	IS20-25/C55 SA
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Leak/Splash (1354)
Health Effect - Clinical Codes	Intimal Dissection (1333); Aneurysm (1708); Failure of Implant (1924); Rupture (2208); Blood Loss (2597)
Date of Event	01/30/2016
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
Patient had an emergent rupture and was initially implanted with a bifurcated, two infrarenal aortic extensions, a suprarenal aortic extension, and a limb extension on (b)(6) 2016.The patient came in emergently on (b)(6) 2016 with abdominal pain and computed tomography revealed possible endoleak.Patient was admitted and an angiogram confirmed type 1b endoleak with sac growth.Physician elected to implant competitor device to seal the endoleak.Patient is in stable condition.
Additional Manufacturer Narrative
Additional information was found from a computed tomography of a type ii and an unknown endoleak.

• Brand Name: AFX
• Common Device Name: LIMB
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 5466247
• Report Number: 2031527-2016-00078
• Device Sequence Number: 10824944
• Product Code: MIH
• UDI-Device Identifier: 00818009011466
• UDI-Public: (01)00818009011466
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• 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,Followup
• Report Date (Section B): 01/30/2016

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: 01/27/2018
• Device Model Number: IS20-25/C55 SA
• Device Lot Number: 1253183-003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/30/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/29/2016
• Supplement Report FDA Received Date: 05/03/2016
• 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: 69 YR