MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; LIMB STENT GRAFT

Model Number	IS20-25/C65 SA
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Rupture (2208)
Date of Event	04/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation and remain implanted in the patient.If additional information is obtained at a later time that is pertinent to this event, a follow-up report will then be submitted.
Event or Problem Description
On (b)(6) 2018 the patient visited the er at (b)(6) medical center due to pain from a retroperitoneal bleed per cta, with no obvious endoleak.The bleed was noted on the right side where the patient had a prior repair for iliac aneurysm.Patient was stable and brought to the or for an angiogram and possible repair.On angiogram an endoleak was not detected for the right or left side.Per the physician, passing a wire up through the iliac stents on the right side was challenging, and they noticed the overlap or transition between one of the overlapped iliac components was narrowed and "didn't look right," therefore, they ballooned the right iliac limb overlap and the procedure was completed successfully.

• Brand Name: AFX
• Common Device Name: LIMB STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7473607
• Report Number: 2031527-2018-00398
• Device Sequence Number: 16407060
• Product Code: MIH
• UDI-Device Identifier: 00818009011473
• UDI-Public: (01)00818009011473(17)180108
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/30/2018

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: Physician
• Device Expiration Date: 01/08/2018
• Device Model Number: IS20-25/C65 SA
• Device Lot Number: 1253199-016
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2018
• Initial Report FDA Received Date: 04/30/2018
• 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: AFX-BIFURCATED STENT GRAFT - LOT 1339167-020; AFX-LIMB STENT GRAFT - LOT 1339099-007; AFX-LIMB STENT GRAFT - LOT 1350055-002; AFX-LIMB STENT GRAFT - LOT 1350055-003
• Outcome Attributed to Adverse Event: Required Intervention