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

Model Number	TV-IL1416120-J
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	03/15/2019
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 afx2 bifurcated stent graft, an afx vela suprarenal, two (2) afx limb stent grafts, and an ovation ix iliac limb were implanted to treat an abdominal aortic aneurysm (aaa).In addition, the right hypogastric artery was coiled.Approximately three (3) years post op, a routine follow-up ct identified an iliac aaa (unknown diameter) on the right side and the ovation ix iliac limb has moved up into the iliac aaa.Re-intervention was completed with implant of an ovation iliac limb.
Event or Problem Description
Additional information received reporting that a type ib endoleak was also present.In addition, the secondary intervention successfully sealed the endoleak and the patient was reportedly stable postoperative.
Additional Manufacturer Narrative
A clinical 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 no response was received.As such, event determination, off-label conditions, related patient harms, and patient disposition could not be independently assessed.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: 8542400
• Report Number: 3008011247-2019-00067
• Device Sequence Number: 11198663
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1416120J1
• UDI-Public: +M701TVIL1416120J1/$$3190509FS01181611P
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/09/2019
• Device Model Number: TV-IL1416120-J
• Device Catalogue Number: TV-IL1416120-J
• Device Lot Number: FS011816-11
• 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: 04/23/2019
• 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: AFX LIMB STENT GRAFT (LN 1298065001).; AFX LIMB STENT GRAFT (LN 1299325014).; AFX VELA SUPRARENAL (LN 1484367010).; AFX2 BIFURCATED STENT GRAFT (LN 1356566031).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR