MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number	A25-25/C95-O20 V
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Leak/Splash (1354); Unintended Movement (3026)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/09/2018
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.During the procedure, the 25 vela moved downwards (implant movement) which caused a type iiia endoleak (separation between the main body and cuff).In response the physician implanted a 28 vela (5mm proximal to 25 vela) to ensure a sealed neck; a palmaz (non-endologix) stent was also implanted to resolve the leak.However, two (2) days after the index procedure was completed, a follow-up ct was performed which confirmed that the intraoperative endoleak has persisted.The physician plans to re-intervene and will continue to monitor the patient.It is unknown if the patient is symptomatic.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 unsubstantial evidence to support the reported event of vela implant movement.The resultant intraoperative type iiia and persistent type iiia endoleak are refuted by medical documentation; rather, a procedure-related harm of an intraoperative and post-operative type ii endoleak was present.Therefore, this complaint is most likely anatomy-related.The patient is awaiting a secondary repair procedure; the final patient status could not be confirmed and was not reported.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 codes - remove 1068, 1354.Conclusion code - remove 11.
Event or Problem Description
Additional information received per clinical assessment refuting the reported type iiia endoleak; rather, an intraoperative and persistent type ii endoleak was present.

• Brand Name: AFX
• Common Device Name: VELA SUPRARENAL
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8148768
• Report Number: 2031527-2018-00933
• Device Sequence Number: 1407384
• Product Code: MIH
• UDI-Device Identifier: 00818009013620
• UDI-Public: (01)00818009013620(17)200731
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2018

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: 07/31/2020
• Device Model Number: A25-25/C95-O20 V
• Device Lot Number: 1725690-013
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/11/2018
• Supplement Date Received by Manufacturer: 11/11/2018
• Initial Report FDA Received Date: 12/10/2018
• Supplement Report FDA Received Date: 03/12/2019
• 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-VELA SUPRARENAL:1950323-003; AFX2-AFX2 BIFURCATED STENT GRAFT:1930164-010
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR