MAUDE Adverse Event Report: TRIVASCULAR, INC. OVATION PRIME; MAIN BODY

Model Number TV-AB2680-J

Device Problems Material Invagination (1336); Malposition of Device (2616)

Patient Problems Occlusion (1984); Pain (1994); Stenosis (2263)

Event Date 01/05/2017

Event Type  Injury  

Manufacturer Narrative

Remains implanted.

Event Description

An ovation ix abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.The 1 month post operative ct showed narrowing at the level of the aortic body stent graft sealing rings due to the stent graft being placed below the intended landing zone, placing the sealing rings in a location where the aortic diameter is smaller than the implanted stent graft.A re-intervention is planned at a later date to place a balloon expandable stent at the level of the sealing rings.As of the date of this report, the re-intervention has not been scheduled and the patient will continue to be monitored.There have been no additional patient sequelae reported.

Manufacturer Narrative

Based on the clinical assessment for this event, the most likely cause of the reported occlusion within the device was determined to be anatomy related.A clinical assessment showed that the device did not likely contribute to the event.Procedure-related circumstances were found to not likely have contributed to this event.Anatomical factors such as the patient's pre-existing iliac artery occlusive disease most likely contributed to the occlusion within the device.There were no user-related, off-label, or cautionary product use conditions found.A review of the device quality records shows that the device demonstrated compliance to established procedures and specifications at the time of manufacture.(b)(4).

Event Description

An ovation prime abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.The patient returned unscheduled at an unknown date with symptoms of abdominal pain.A cat scan was completed and it was observed that the stent graft was thrombosed from the inferior renal artery to the common femoral artery.The patient returned approximately 2.5 years post-op for a re-intervention to implant an axial bi-femoral surgical graft, which partially resolved perfusion through the stent graft system.There have been no additional patient sequelae reported.

• Brand Name: OVATION PRIME
• Type of Device: MAIN BODY
• Manufacturer (Section D): TRIVASCULAR, INC.; 3910 brickway blvd.; santa rosa CA 95403
• Manufacturer (Section G): TRIVASCULAR, INC.; 3910 brickway blvd.; santa rosa CA 95403
• Manufacturer Contact: michelle caulfield ; 2 musick; irvine, CA 92618 ; 8009832284
• MDR Report Key: 6326950
• MDR Text Key: 67280959
• Report Number: 3008011247-2017-00013
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2680J1
• UDI-Public: +M701TVAB2680J1/$$3190822FS040116010
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/13/2017

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: Physician
• Device Expiration Date: 08/22/2019
• Device Model Number: TV-AB2680-J
• Device Catalogue Number: TV-AB2680-J
• Device Lot Number: FS040116-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/13/2017
• Initial Date FDA Received: 02/13/2017
• Supplement Dates Manufacturer Received: 01/13/2017
• Supplement Dates FDA Received: 08/17/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/22/2016
• 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): Other
• Patient Age: 65 YR