MAUDE Adverse Event Report: ENDOLOGIX OVATION PRIME; MAIN BODY

Model Number	TV-AB2380-E
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	05/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in the event will not be returned for evaluation, they remain implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
An ovation ix abdominal stent graft system was implanted to treat an abdominal aortic aneurysm in 2015.Endologix was made aware of an enlarged aaa on a patient during a routine follow up ct.It was noted that the aaa has grown 1cm since the initial implant.Physician also observed in the ct a slight blush of contrast around the aortic body indicating a leak of unknown origin.Patient continues to be monitored, there were no discussion on a reintervention, patient will be monitored.Patient condition is good otherwise.
Additional Manufacturer Narrative
At the conclusion of the investigation, the sac growth complaint is confirmed.The complaint is most likely anatomy related.The procedure related harms identified were type ii endoleak (not a device failure) from the lumbar artery observed at 3month and 35month ct post the initial implant.The final patient status was reported to be in good condition and on surveillance.The review of manufacturing lot confirmed all devices met specifications prior to release.Devices remain implanted in the patient and were not returned, no evaluation completed.This complaint is not capa eligible at this time.These types of events will be monitored and trended as part of the quality system.Correction: (b)(4).

• Brand Name: OVATION PRIME
• Common Device Name: MAIN BODY
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 7589553
• Report Number: 3008011247-2018-00128
• Device Sequence Number: 2292327
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2380E1
• UDI-Public: +M701TVAB2380E1/$$3180106FS10241403V
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2018

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: No Information
• Device Expiration Date: 01/06/2018
• Device Model Number: TV-AB2380-E
• Device Catalogue Number: TV-AB2380-E
• Device Lot Number: FS102414-03
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/01/2018
• Supplement Date Received by Manufacturer: 08/03/2018
• Initial Report FDA Received Date: 06/11/2018
• Supplement Report FDA Received Date: 08/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR