MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA28-80/I20-40
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924); No Code Available (3191)
Date of Event	04/01/2019
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, aneurysm sac expansion with billowing and a type iiia endoleak (no component separation) were detected during routine follow-up; it was noted that the patient had a pre-existing anterior tortuous anatomy.The physician plans to perform an angiogram to confirm the reported events and to re-intervene by implanting an additional vela proximal extension.The patient is reportedly doing well.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 refute the reported events of aneurysm sac growth and a type iiia endoleak.Rather, there was a confirmed loss of overlap between the bifurcated device and suprarenal extension; the overlap at time of event measured at 22mm (ifu states overlap requirement is 40mm).Due to the lack of medical images, unable to confirm if the loss of overlap was a result of malposition at time of initial implant, or due to device movement post initial implant.Contributing factors for the loss of overlap could be the off-label neck diameter of 38.0mm at the time of implant (ifu requirement between 18-32mm).The secondary endovascular procedure is confirmed.Procedure-related harms and device, user, procedure, or anatomy relatedness of this event could not be determined.The final patient status is reportedly stable.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.Correction removal reporting number; remove z-0006-2019.
Event or Problem Description
Additional information received confirming that the physician elected to treat the patient by implanting two (2) additional suprarenal afx devices on (b)(6) 2019.No leak was noted at the conclusion of the secondary intervention per postoperative angiogram.In addition, the reported type iiia endoleak with sac growth were refuted per clinical assessment; rather, an off-label neck diameter (38mm) at initial implant and loss of overlap were confirmed.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8522577
• Report Number: 2031527-2019-00188
• Device Sequence Number: 13924144
• Product Code: MIH
• UDI-Device Identifier: 00818009012265
• UDI-Public: (01)00818009012265(17)190120
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,health
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2019

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: 01/20/2019
• Device Model Number: BA28-80/I20-40
• Device Lot Number: 1285678-011
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/01/2019
• Supplement Date Received by Manufacturer: 04/01/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 06/24/2019
• 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-0006-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX-VELA SUPRARENAL:1449834-016; AFX-VELA SUPRARENAL:1449834-016
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 73 YR