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

Model Number	TV-IL1428160-J
Medical Device Problem Codes	Leak/Splash (1354); Unintended Movement (3026)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted in the patient and will not be returned for evaluation.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.It was noted that the index procedure was semi-emergent as the patient was seen by a doctor for other reasons when an 8cm aaa was discovered with bilateral common iliac ectasia, and a high degree of iliac tortuosity on the left side.The patient was originally treated with bilateral ovation 28mm iliac limbs, knowing that the left limb may not have long-term seal.The patient returned for the two (2) month routine follow-up presenting with a type ib endoleak.A re-intervention was performed on (b)(6) 2018; however, the type ib endoleak was not sealed.The new limb was not able to track and was not deployed.The original limb had already pulled out of the iliac prior to the secondary attempt.The patient was stable at the conclusion of the case.On (b)(6) 2018, the patient was treated with implant of two ovation ix iliac limbs.As of the date of this report, there have been no additional patient sequelae reported.
Additional Manufacturer Narrative
An evaluation of the reported event could not be completed due to a lack of receipt of relevant medical records and/or imaging.Requests were made and denied response were received.As such, event determination, off label conditions, related patient harms and patient disposition could not be independently assessed.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: ILIAC LIMB
• Manufacturer (Section D): ENDOLOGIX (TRIVASCULAR INC.); 3910 brickway blvd.; santa rosa CA 95403
• MDR Report Key: 7974783
• Report Number: 3008011247-2018-00224
• Device Sequence Number: 11066205
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1428160J1
• UDI-Public: +M701TVIL1428160J1/$$3210503FS02241870O
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2018

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: 05/03/2021
• Device Model Number: TV-IL1428160-J
• Device Catalogue Number: TV-IL1428160-J
• Device Lot Number: FS022418-70
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/17/2018
• Supplement Date Received by Manufacturer: 12/12/2018
• Initial Report FDA Received Date: 10/17/2018
• Supplement Report FDA Received Date: 02/14/2019
• 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 FS040518-30); OVATION IX MAIN BODY (LN FS050218-36); OVATION IX ILIAC LIMB (LN FS040518-30); OVATION IX MAIN BODY (LN FS050218-36)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR