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

Model Number	IS20-25/C55 SA
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Leak/Splash (1354)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	01/22/2018
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.
Event or Problem Description
On (b)(6) 2016, the patient was initially implanted with a bifurcated stent, a suprarenal extension and two (2) limb extensions.On (b)(6) 2018, endologix was made aware of a 3a endoleak with graft movement on the suprarenal extension and 1b endoleak on the left limb.The patient was admitted to the hospital with abdominal pain.The physician elected to implant two (2) additional extensions to address the 3a endoleak / graft movement and implant an ovation limb extension to address the 1b endoleak.The patient was reported as stable post-secondary procedure.On (b)(6) 2018, endologix was made aware that the patient had expired about a week post-secondary procedure.The physician did not provide an exact date or cause of death.There is no additional information at this time.This mdr (2031527-2018-00105) will cover the 1b endoleak of the left limb.A separate mdr (2031527-2018-00104) will cover the 3a endoleak with graft movement of the suprarenal extension as well as the reported death.
Additional Manufacturer Narrative
The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned as the device remains implanted therefore no evaluation was completed.At the completion of the clinical assessment, clinical was able to find substantial evidence to support the following events of a type 1b endoleak and stent cage dilation of 20% of the limb.The most likely cause of the compromised stent graft integrity (dilation) of the limb extension could not be determined.The most likely cause of the distal loss of seal was a tortuous iliac artery and an incomplete seal noted on the implant angiogram.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.

• Brand Name: AFX
• Common Device Name: LIMB STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7286448
• Report Number: 2031527-2018-00105
• Device Sequence Number: 11040276
• Product Code: MIH
• UDI-Device Identifier: 00818009011466
• UDI-Public: (01)00818009011466(17)170925
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2018

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: Health Professional
• Device Expiration Date: 09/25/2017
• Device Model Number: IS20-25/C55 SA
• Device Lot Number: 1253179-024
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/22/2018
• Supplement Date Received by Manufacturer: 01/22/2018
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 05/09/2018
• 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: BIFURCATED STENT, LOT # 1519685030; LIMB EXTENSION, LOT # 1472912-006; SUPRARENAL EXTENSION, LOT # 1605738-004; BIFURCATED STENT, LOT # 1519685030; LIMB EXTENSION, LOT # 1472912-006; SUPRARENAL EXTENSION, LOT # 1605738-004
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR