MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA25-100/I20-40
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Leak/Splash (1354); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	10/22/2018
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
The patient was initially treated with the afx abdominal aortic aneurysm stent.Approximately three (3) years post initial procedure, a type 1b endoleak and aneurysm sac growth was detected.The physician elected to treat the patient by implanting an three (3) limb afx devices on (b)(6) 2018.The patient was stable when leaving the operating room.There have been no additional patient sequelae reported.
Additional Manufacturer Narrative
A clinical evaluation of the reported event could not be completed due to a lack of receipt of relevant medical records and/or imaging; requests were made and denied.As such, event determination, off-label conditions, related patient harms, and patient disposition could not be independently assessed.The manufacturing lot review confirmed all devices met specifications prior to release.These types of events will be monitored and trended as part of the quality system.Device code - remove 1068, 1354.Conclusion code - remove 11.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8091579
• Report Number: 2031527-2018-00866
• Device Sequence Number: 1501915
• Product Code: MIH
• UDI-Device Identifier: 00818009014108
• UDI-Public: (01)00818009014108(17)180114
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 10/22/2018

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: 01/14/2018
• Device Model Number: BA25-100/I20-40
• Device Lot Number: 1310988-027
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/22/2018
• Supplement Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 11/20/2018
• Supplement Report FDA Received Date: 02/22/2019
• 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 STENT GRAFT:1252598-025; AFX-VELA SUPRARENAL:1252402-013; AFX-LIMB STENT GRAFT:1252598-025; AFX-VELA SUPRARENAL:1252402-013
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 88 YR