MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; LIMB

Model Number	I16-16/C88 SA
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Leak/Splash (1354)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924); Pain (1994); Rupture (2208)
Date of Event	01/25/2017
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.Devices remain implanted in the patient.
Event or Problem Description
It was reported the patient had an initial procedure on (b)(6) 2014 with a bifurcated, an infrarenal aortic extension, a suprarenal aortic extension, and a limb stent graft.On (b)(6) 2015 the patient had a subsequent endovascular procedure to repair a type 1b endoleak, two limb stents were placed in the right iliac artery.On (b)(6) 2017 the patient came in emergently with pain, computed tomography (ct) showed an expanding iliac aneurysm in the left iliac artery.The physician elected to implant a non-endologix device as a left limb extension (medtronic aui).At the completion of the intervention the physician noted a type 3a endoleak between the main body and the non-endologix stent.The patient will be monitored and is scheduled to return for a 30-day ct.It has been reported the patient was in stable condition at the completion of the procedure.
Additional Manufacturer Narrative
Based upon additional information, clinical evaluation identified the following observations: aneurysmal sac growth of the aorta, and rupture of the aorta at 30 months post-op (right retroperitoneal bleeding).Based upon the available information, the root cause of the reported type ib endoleak was likely off-label usage, as the iliac limb anatomy was outside of the treatment range.At the completion of the clinical evaluation, there was no evidence to support the following reported events: pain, type iiia endoleak of the left iliac, third endovascular procedure, and non-endologix stent implantation.The manufacturing lot record evaluation confirmed all devices met specifications prior to release.The device was not returned, therefore, sample evaluation was not completed.

• Brand Name: AFX
• Common Device Name: LIMB
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 6358518
• Report Number: 2031527-2017-00081
• Device Sequence Number: 11023518
• Product Code: MIH
• UDI-Device Identifier: 00818009011404
• UDI-Public: (01)00818009011404(17)171219
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: PO40002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2017

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: 12/19/2017
• Device Model Number: I16-16/C88 SA
• Device Lot Number: 1253152-016
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/25/2017
• Supplement Date Received by Manufacturer: 01/25/2017
• Initial Report FDA Received Date: 02/24/2017
• Supplement Report FDA Received Date: 07/03/2017
• 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: AORTO UNI-ILIAC [INFRARENAL]- 1217430-019; AORTO UNI-ILIAC [SUPRARENAL]- 1260326-011; BIFURCATED- 1259696-032; LIMB- 1047172-028; LIMB- 1350054-025
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR