MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA22-80/I16-40
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Leak/Splash (1354); Material Puncture/Hole (1504)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/13/2018
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
The patient was being treated to for an aneurysm.During the procedure the physician performed an angiography which revealed a type 1a endoleak.Though type 1b endoleak was also suspected, considering angiography observation, it was found to be type 3b endoleak.The type 1a endoleak was resolved intraoperatively.The type 3b endoleak appeared to have derived from a bifurcation of the main body, and that brought a conclusion that a pinhole or tears were due to proximal edge of a non-endologix stent used.As of the date of this report there have been no additional patient sequelae reported.The patient status patient is being monitored and no secondary procedure was scheduled.No additional information was provided.
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.A clinical assessment of the reported event could not be completed due to a lack of receipt of relevant medical records and/or imaging.Several attempts were made to obtain medical records and images.However it was reported that the pinhole of the graft (type 3b endoleak) could have been made at that time as the graft was implanted by the proximal edge of a non- endolgox (palmaz) stent.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 7966018
• Report Number: 2031527-2018-00777
• Device Sequence Number: 1395419
• Product Code: MIH
• UDI-Device Identifier: 00818009015006
• UDI-Public: (01)00818009015006(17)190212
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2018

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: 02/12/2019
• Device Model Number: BEA22-80/I16-40
• Device Lot Number: 1784914003
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/18/2018
• Supplement Date Received by Manufacturer: 10/24/2018
• Initial Report FDA Received Date: 10/15/2018
• Supplement Report FDA Received Date: 12/13/2018
• 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-LIMB EXTENSION-LOT: 1680193016; AFX-LIMB EXTENSION-LOT: 1780377010; AFX-LIMB EXTENSION-LOT: 1680193016; AFX-LIMB EXTENSION-LOT: 1780377010
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR