MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA28-100/I20-40
Medical Device Problem Codes	Leak/Splash (1354); Material Puncture/Hole (1504); Deformation Due to Compressive Stress (2889); Material Integrity Problem (2978)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/02/2018
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) 2015, the patient was implanted with a bifurcated and a suprarenal extension to treat an abdominal aortic aneurysm.On (b)(6) 2018, endologix was made aware of unknown endoleak (possible 3a or/and 3b).On (b)(6) 2018, the physician elected to reline the original implanted devices with ovation main body, extender and two (2) limbs stent grafts.During the secondary procedure, the physician mentioned that the patient had a peripheral intervention at some point with stents placed in the right iliac artery.He noted the main body was considerably foreshortened, and felt that during the peripheral intervention, that "something" had happened to the graft".Possibly wire entrapment with aggressive removal could have possibly caused the foreshortening.The patient was reported in good condition post secondary procedure.There have been no additional patient sequelae reported.
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 type 3b endoleak, complete distal stent buckling and stent cage dilation of the main body stent.Procedure related harms, device, user, procedure or anatomy relatedness of this complaint could not be determined based on the information shared with endologix to review.The final patient status was reported to be stable post-secondary endovascular procedure.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 7646820
• Report Number: 2031527-2018-00565
• Device Sequence Number: 16174437
• Product Code: MIH
• UDI-Device Identifier: 00818009014207
• UDI-Public: (01)00818009014207(17)171103
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 06/02/2018

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: 11/03/2017
• Device Model Number: BA28-100/I20-40
• Device Lot Number: 1284147-007
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/02/2018
• Supplement Date Received by Manufacturer: 06/02/2018
• Initial Report FDA Received Date: 06/28/2018
• Supplement Report FDA Received Date: 09/19/2018
• 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: SUPRARENAL EXTENSION, LOT # 1252057018; SUPRARENAL EXTENSION, LOT # 1252057018
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR