MAUDE Adverse Event Report: ENDOLOGIX (TRIVASCULAR INC.) OVATION IX; ILIAC LIMB

Model Number	TV-IL1422140-J
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Date of Event	03/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Endologix will continue to investigate the reported event.The patient medical records and imaging studies have been requested for further evaluation by a clinical specialist.A final report will be submitted once the investigation of the reported event has concluded.
Event or Problem Description
An ovation ix abdominal stent graft system was implanted to treat an abdominal aortic aneurysm (aaa).Reportedly, the patient was diagnosed with renal insufficiency prior to the initial ovation implant (pre-existing and non-aaa-related).The ovation stent graft system landed and deployed as expected during the initial procedure.Approximately three (3) years post op, the routine follow-up non-con ct identified aaa sac growth from 6cm to 7cm compared to the previous year in addition to a possible type 1b or type ii endoleak.The patient is being monitored.
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 an indeterminate endoleak due to a lack of relevant imaging.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 under surveillance pending a diagnostic angiogram.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.

• Brand Name: OVATION IX
• Common Device Name: ILIAC LIMB
• Manufacturer (Section D): ENDOLOGIX (TRIVASCULAR INC.); 3910 brickway blvd.; santa rosa CA 95403
• MDR Report Key: 8537501
• Report Number: 3008011247-2019-00066
• Device Sequence Number: 10854601
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1422140J1
• UDI-Public: +M701TVIL1422140J1/$$3190429FS02121619S
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/29/2019
• Device Model Number: TV-IL1422140-J
• Device Catalogue Number: TV-IL1422140-J
• Device Lot Number: FS021216-19
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 04/22/2019
• Supplement Report FDA Received Date: 06/20/2019
• 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: OVATION IX EXTENDER (LN FS100815-14).; OVATION IX ILIAC LIMB (LN FS100615-08).; OVATION IX MAIN BODY (LN FS030216-40).; OVATION IX EXTENDER (LN FS100815-14); OVATION IX ILIAC LIMB (LN FS100615-08); OVATION IX MAIN BODY (LN FS030216-40)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 87 YR