MAUDE Adverse Event Report: TRIVASCULAR, INC. OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM; ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM

Model Number TV-AB3480-E

Device Problem Material Invagination (1336)

Patient Problem Numbness (2415)

Event Date 09/05/2014

Event Type  Injury  

Event Description

An ovation prime abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.The patient returned on (b)(6) 2014 with numbness in the legs and the follow-up angiogram and ct demonstrates good flow through and evidence of in-folding of the stent graft at the level of the sealing rings.The patient started physical therapy on (b)(6) 2014 and will continue to be monitored; as of the date of this report there have been no additional sequelae reported and no planned re-intervention.

Manufacturer Narrative

Remains implanted.

• Brand Name: OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM
• Type of Device: ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM
• 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: alexis weil ; 3910 brickway blvd.; santa rosa, CA 95403 ; 7075438835
• MDR Report Key: 4164656
• MDR Text Key: 4875174
• Report Number: 3008011247-2014-00086
• Device Sequence Number: 1
• Product Code: MIH
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/11/2014

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: 03/31/2017
• Device Model Number: TV-AB3480-E
• Device Catalogue Number: TV-AB3480-E
• Device Lot Number: FS021914-19
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/11/2014
• Initial Date FDA Received: 10/10/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/31/2014
• 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: 81 YR