MAUDE Adverse Event Report: ENDOLOGIX (TRIVASCULAR INC.) OVATION IX; MAIN BODY

Model Number	TV-AB2380-J
Medical Device Problem Codes	Off-Label Use (1494); Malposition of Device (2616)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/06/2019
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.Reportedly, the case was off label as the juxtarenal angle was greater than the ifu guidelines.The main body landed lower than the intended seal zone causing a type ia endoleak.A non-endologix (palmaz) stent was deployed to seal the type ia endoleak; however, it did not completely resolve the endoleak.The physician decided to leave as is and if the type ia endoleak does not resolve in 30 days the need for re-intervention will be determined.The patient is being monitored.
Additional Manufacturer Narrative
Based on the description of the event and provided medical records, clinical assessment confirmed the reported events of the type ia endoleak and the malposition.There were no procedure related harms identified.The final patient disposition was discharge home in good condition one day post-operative.The most likely root cause for the type ia endoleak was the off-label neck anatomy which was at a 110-degree angle.Per the instructions for use (ifu) the neck anatomy should be less than or equal to 60 degrees.Per the ifu this was also cautionary product use due to the neck calcifications.The root cause for the malposition of the proximal graft was the highly tortuous neck which caused the second sealing ring to land in the aneurysmal sac.In addition, this was an off ifu case due to the concomitant use of non endologix products (proximal stent in right iliac artery as well as distal stent in left external iliac artery).The review of manufacturing lot confirmed all devices met specifications prior to release.No additional investigations of this reported complaint are planned.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.

• Brand Name: OVATION IX
• Common Device Name: MAIN BODY
• Manufacturer (Section D): ENDOLOGIX (TRIVASCULAR INC.); 3910 brickway blvd.; santa rosa CA 95403
• MDR Report Key: 8488222
• Report Number: 3008011247-2019-00054
• Device Sequence Number: 2689729
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2380J1
• UDI-Public: +M701TVAB2380J1/$$3210619FS061218346
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2019

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: 06/19/2021
• Device Model Number: TV-AB2380-J
• Device Catalogue Number: TV-AB2380-J
• Device Lot Number: FS061218-34
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/06/2019
• Supplement Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 04/05/2019
• Supplement Report FDA Received Date: 05/24/2019
• 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 ILIAC LIMB (LN FS010518-25).; OVATION IX ILIAC LIMB (LN FS080918-45).; PALMAZ STENT (NON-ENDOLOGIX).; OVATION IX ILIAC LIMB (LN FS010518-25); OVATION IX ILIAC LIMB (LN FS080918-45); PALMAZ STENT (NON-ENDOLOGIX)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR