MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA28-100/I16-40
Medical Device Problem Codes	Fracture (1260); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Date of Event	04/22/2019
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 for an abdominal aortic aneurysm (aaa) with the afx abdominal aortic aneurysm stent.Approximately three (3) years post initial procedure, a stent fracture was detected during routine follow-up.The physician elected to treat the patient by successfully relining with a bifurcated afx2 and suprarenal afx devices on (b)(6) 2019.The patient was reportedly in good condition.There have been no additional patient sequelae reported.
Event or Problem Description
Additional information received per clinical assessment confirming that the patient was initially treated on an emergent basis (off-label use) due to a ruptured abdominal aortic aneurysm (aaa).
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 a stent fracture.The procedure-related harms and device, user, procedure, or anatomy relatedness of this event could not be determined.The final patient status was reported to be in good condition following a successful endovascular re-line procedure.No contributing factors were identified.The discharge summary did note the patient was ruptured prior to the initial implant.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 iteration is afx with duraply.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8579359
• Report Number: 2031527-2019-00220
• Device Sequence Number: 1731505
• Product Code: MIH
• UDI-Device Identifier: 00818009010049
• UDI-Public: (01)00818009010049(17)170822
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2019

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: 08/22/2017
• Device Model Number: BA28-100/I16-40
• Device Lot Number: 1268467-026
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/22/2019
• Supplement Date Received by Manufacturer: 04/22/2019
• Initial Report FDA Received Date: 05/03/2019
• Supplement Report FDA Received Date: 07/10/2019
• 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:1252616-002; AFX-VELA SUPRARENAL:1370930-007; AFX-LIMB STENT GRAFT:1252616-002; AFX-VELA SUPRARENAL:1370930-007
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR