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

Model Number TV-AB3480-J

Device Problems Collapse (1099); Improper or Incorrect Procedure or Method (2017); Deformation Due to Compressive Stress (2889)

Patient Problem Occlusion (1984)

Event Date 06/03/2019

Event Type  Injury  

Manufacturer Narrative

The lot history records related to the subject device referenced in this complaint record were reviewed for potential contributing factors for the failure mode(s) described in this event.A review of the device quality records showed that the device(s) demonstrated compliance to established procedures and specifications at the time of manufacture.

Event Description

The patient was initially treated for an abdominal aortic aneurysm (aaa) with the ovation ix abdominal stent graft system.During the initial procedure the physician was unable to confirm if cannulation of the contra gate occurred due to the lateral c-arm position and the large body habitus.In the attempt to ensure the cannulation of the same limb had occurred, the physician inflated (2) 12x4 balloons to 1 atm.After inflation of the balloon the physician was able to confirm that both wires were present in the lpsi limb.The physician attempted to get in the contra gate retrograde but was unable to do so.The physician then used a rim catheter in an attempt to snare a wire from over the flow-divider however, unsuccessful.The physician performed an angiogram where it was determined that the contra aortic body leg appeared crushed with an absence of flow.The physician then elected to plug the contra common iliac and perform a fem-fem bypass/aui which successfully restored flow.The patient was reported as discharged and doing well.

Manufacturer Narrative

Clinical assessment of the reported event was unable to be completed due to a lack of receipt of relevant medical records and/or imaging.Requests were made for medical records; however, denied.Requests were made for medical imaging; however, no response was received.As such, event determination, off label conditions, related patient harms and patient disposition could not be assessed.The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device remains implanted; therefore, no device evaluation was completed.No additional investigation of this reported event is planned; however, if additional information pertinent to the incident is obtained, a follow-up report will be submitted.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.

• Brand Name: OVATION IX
• Type of Device: AORTIC MAIN BODY
• Manufacturer (Section D): ENDOLOGIX (TRIVASCULAR); 3910 brickway blvd; santa rosa CA 95403
• MDR Report Key: 8759634
• MDR Text Key: 150012888
• Report Number: 3008011247-2019-00103
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: M701TVAB3480J1
• UDI-Public: +M701TVAB3480J1/$$3220419FS04161908B
• Combination Product (y/n): N
• PMA/PMN Number: P120006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/03/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 04/19/2022
• Device Model Number: TV-AB3480-J
• Device Catalogue Number: TV-AB3480-J
• Device Lot Number: FS041619-08
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/03/2019
• Initial Date FDA Received: 07/03/2019
• Supplement Dates Manufacturer Received: 06/03/2019
• Supplement Dates FDA Received: 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OVATION CUSTOM SEAL FILL POLYMER - LOT FF013019-04.; OVATION IX ILIAC LIMB - LOT FS0101918-14.; OVATION CUSTOM SEAL FILL POLYMER - LOT FF013019-04; OVATION IX ILIAC LIMB - LOT FS0101918-14
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR