MAUDE Adverse Event Report: ENDOLOGIX OVATION IX; ILIAC LIMB

Model Number	TV-IL1414140-J
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Failure of Implant (1924); Occlusion (1984)
Date of Event	08/01/2018
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 2017.Recently, on an unknown date, it was reported that the patient presented at the hospital with occluded endograft with bilateral limb ischemia.Re-intervention was performed on (b)(6) 2018 at a hospital not affiliated with endologix; therefore, no information could be obtained regarding the secondary procedure.

• Brand Name: OVATION IX
• Common Device Name: ILIAC LIMB
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 7801100
• Report Number: 3008011247-2018-00181
• Device Sequence Number: 19199724
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1414140J1
• UDI-Public: +M701TVIL1414140J1/$$3200824FS08151720M
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/01/2018

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: 08/24/2020
• Device Model Number: TV-IL1414140-J
• Device Catalogue Number: TV-IL1414140-J
• Device Lot Number: FS081517-20
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2018
• Initial Report FDA Received Date: 08/21/2018
• 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 LIMB-LOT: FS081817-19; OVATION MAIN BODY-LOT: FS052617-42
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR