MAUDE Adverse Event Report: ENDOLOGIX AFX; LIMB STENT GRAFT

Model Number	I20-13/C88F SA
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Leak/Splash (1354)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the completion of the clinical evaluation and based on the information received, there was unsubstantial evidence to support the reported event of type ib endoleak.There was evidence to reasonably support that a non-endologix stent was implanted distal to the left iliac (23mm between stents) per ct scan on (b)(6) 2016 (off-label).Device, user, procedure or anatomy relatedness of this complaint could not be determined.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.This complaint is not capa eligible at this time.These types of events will be monitored and trended as part of the quality system.
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 ib endoleak was detected.The physician elected to treat the patient by implanting an extender ovation ix device and coiling the hypogastric artery on (b)(6) 2016.There have been no additional patient sequelae reported.

• Brand Name: AFX
• Common Device Name: LIMB STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8169906
• Report Number: 2031527-2018-00942
• Device Sequence Number: 1326568
• Product Code: MIH
• UDI-Device Identifier: 00818009011459
• UDI-Public: (01)00818009011459(17)180821
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 12/05/2016

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: 08/21/2018
• Device Model Number: I20-13/C88F SA
• Device Lot Number: 1252611-018
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2016
• Initial Report FDA Received Date: 12/17/2018
• 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-BIFURCATED STENT GRAFT:1251936-001
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR