MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; LIMB

Model Number	IS20-25/C65 SA
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Leak/Splash (1354)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/21/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in the event will not be returned for evaluation, they remain implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
Patient was initially implanted with a bifurcated stent, a suprarenal aortic extension, and two limb stents.In investigating another event the clinical evaluation identified an unreported subsequent endovascular procedure.The patient was treated for a type 1b endoleak where the physician elected to implant a non-endologix palmaz stent.The physician additionally completed angioplasty on the right iliac limb.
Additional Manufacturer Narrative
At the completion of the clinical evaluation, based on the information received the following were confirmed; endoleak type ib, second endovascular repair with a non-endologix bare metal stent and angioplasty.The clinical assessment was based on adequate patient medical records, and adequate patient images.Based on the information available the root cause of the reported event is unknown.The event device was not returned for further evaluation.Clinical found evidence to reasonably suggest the following contributing factors to the reported event; right distal blushing seen at implant which was thought to be a type ii endoleak, endoleak of the right common iliac at implant, and patient anatomy.This complaint is not capa eligible at this time.These types of events will be monitored and trended as part of the quality system.

• Brand Name: AFX
• Common Device Name: LIMB
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 6429374
• Report Number: 2031527-2017-00118
• Device Sequence Number: 19068320
• Product Code: MIH
• UDI-Device Identifier: 00818009011473
• UDI-Public: (01)00818009011473(17)180131
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2018
• Device Model Number: IS20-25/C65 SA
• Device Lot Number: 1253200-013
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/22/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/23/2017
• Supplement Report FDA Received Date: 06/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BIFURCATED- 1320915-027; LIMB- 1265066-004
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR