MAUDE Adverse Event Report: ENDOLOGIX AFX; INFRARENAL AORTIC EXTENSION

Model Number	A28-28/C55
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Leak/Splash (1354); Dent in Material (2526); Unintended Movement (3026)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/13/2018
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 afx2 abdominal aortic aneurysm stent.Approximately two (2) years post initial procedure, it was discovered that the graft has shifted laterally and the cuff has become "bird beaked" (material invagination) at its distal end with a possible type iiia endoleak, and a type ii endoleak present.The physician plans to reline and will continue to monitor the patient.There have been no additional patient sequelae reported.This report is only for the cuff (infrarenal aortic extension).A separate report will be filed for the main body (bifurcated stent graft).
Additional Manufacturer Narrative
At the completion of the clinical evaluation and based on the information received, there was substantial evidence to support the following observations: no type iiiia andoleak, but presence of a type ii endoleak from lumbar artery.In addition, clinical assessment confirmed that the graft shifted laterally based on the discharge summary.No procedure-related harms post the secondary endovascular procedure were identified.The device, user, procedure, or anatomy relatedness of this complaint could not be determined.The procedure-related harms identified were the type ii endoleak from the lumbar artery.The final patient status was stable and discharged three days post the secondary endovascular procedure.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.
Event or Problem Description
Additional information received confirming that the physician elected to treat the patient by relining with a bifurcated afx2 and an infrarenal afx devices on (b)(6) 2019.In addition, clinical assessment refuted the reported type iiia endoleak.This report is only for the proximal extension (infrarenal aortic extension).Reference mfr.Report # 2031527-2019-00038 for report to the bifurcated stent graft.

• Brand Name: AFX
• Common Device Name: INFRARENAL AORTIC EXTENSION
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8262251
• Report Number: 2031527-2019-00039
• Device Sequence Number: 1672716
• Product Code: MIH
• UDI-Device Identifier: 00818009010278
• UDI-Public: (01)00818009010278(17)18083
• 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): 12/19/2018

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: 08/03/2018
• Device Model Number: A28-28/C55
• Device Lot Number: 1376193-007
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/19/2018
• Supplement Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 01/18/2019
• Supplement Report FDA Received Date: 03/27/2019
• 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: AFX2-AFX2 BIFURCATED STENT GRAFT:1575320-003
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 75 YR