MAUDE Adverse Event Report: ENDOLOGIX AFX; LIMB STENT GRAFT

Model Number	I20-13/C70F SA
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Leak/Splash (1354)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/26/2017
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 one (1) year post initial procedure, a type 1b endoleak was detected ct scan.There have been no additional patient sequelae reported.
Additional Manufacturer Narrative
At the completion of the clinical evaluation and based on the information received, there was substantial evidence to support the reported event of type ib endoleak.The complaint is most likely user-related (off-label absence of aortic aneurysm and incomplete covering of left iliac aneurysm).No contributing factors were identified; unable to determine iliac measurements pre index procedure due to lack of documentation.Procedure related harms for this complaint could not be determined.The final patient status was not reported.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.Conclusion code - remove 11.

• Brand Name: AFX
• Common Device Name: LIMB STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8091661
• Report Number: 2031527-2018-00875
• Device Sequence Number: 16518546
• Product Code: MIH
• UDI-Device Identifier: 00818009011442
• UDI-Public: (01)00818009011442(17)170808
• 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): 10/23/2018

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: 08/08/2017
• Device Model Number: I20-13/C70F SA
• Device Lot Number: 1253169-012
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/23/2018
• Supplement Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 11/20/2018
• Supplement Report FDA Received Date: 01/15/2019
• 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-BIFURCATED STENT GRAFT:1343696-004; AFX-LIMB STENT GRAFT:1257552-002
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR