MAUDE Adverse Event Report: ENDOLOGIX OVATION IX; MAIN BODY

Model Number TV-AB3480-I

Device Problems Failure To Adhere Or Bond (1031); Leak/Splash (1354)

Patient Problem Failure of Implant (1924)

Event Date 05/31/2018

Event Type  Injury  

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 Description

An ovation ix abdominal stent graft system was implanted to treat an abdominal aortic aneurysm in 2018.Patient presented with an endoleak type ia.The physician elected to perform an embolization with coils and onyx to successfully resolve the leak.Patient will is scheduled for a 6 month follow up scan.As of this report, no additional patient sequelae has been reported.

• Brand Name: OVATION IX
• Type of Device: MAIN BODY
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer (Section G): ENDOLOGIX (TRIVASCULAR INC.); 3910 brickway blvd.; santa rosa CA 95403
• Manufacturer Contact: victor arellano ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 7653168
• MDR Text Key: 112837480
• Report Number: 3008011247-2018-00153
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: M701TVAB3480I1
• UDI-Public: +M701TVAB3480I1/$$3200807FS071717126
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P120006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/31/2018

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
• Device Operator: Physician
• Device Expiration Date: 08/07/2020
• Device Model Number: TV-AB3480-I
• Device Lot Number: FS071717-12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/31/2018
• Initial Date FDA Received: 06/29/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/07/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention