MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA22-70/I16-30
Medical Device Problem Codes	Material Puncture/Hole (1504); Product Quality Problem (1506); Material Integrity Problem (2978)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/25/2019
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 afx2 abdominal aortic aneurysm stent.During the initial procedure and after the devices were deployed, angiography showed a type iiib endoleak at the aortic bifurcation.A second bifurcated device was then implanted inside the first, and the endoleak was confirmed resolved.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 type iiib (intraoperative) endoleak of the distal bifurcated device.The procedure-related harms and device, user, procedure, or anatomy relatedness of this event could not be determined.While there were thickened calcifications in the distal aorta with ballooning, which could cause an intraoperative type iiib endoleak, the causation could not be confirmed.The final patient status was not reported, however, it was confirmed that the type iiib endoleak was resolved after a second bifurcated device was implanted.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 afx2.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8591725
• Report Number: 2031527-2019-00229
• Device Sequence Number: 2294708
• Product Code: MIH
• UDI-Device Identifier: 00818009015143
• UDI-Public: (01)00818009015143(17)200214
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2019

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: 02/14/2020
• Device Model Number: BEA22-70/I16-30
• Device Lot Number: 2085676-008
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/25/2019
• Supplement Date Received by Manufacturer: 04/25/2019
• Initial Report FDA Received Date: 05/08/2019
• Supplement Report FDA Received Date: 07/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0007-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX-BIFURCATED STENT GRAFT:BIFURCATED STENT GRAFT; AFX-INFRARENAL AORTIC EXTENSION:1697768-006; AFX2 BIFURCATED STENT GRAFT: 2086180-005; AFX-BIFURCATED STENT GRAFT:BIFURCATED STENT GRAFT; AFX-INFRARENAL AORTIC EXTENSION: 1697768-006
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR