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

Model Number TV-AB3480-E

Device Problems Material Invagination (1336); Leak/Splash (1354); Inadequacy of Device Shape and/or Size (1583)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/16/2015

Event Type  Injury  

Event Description

An ovation prime abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.The one month follow-up ct imaging showed the presence of a type ia endoleak due to implantation of an aortic body stent graft size with a larger diameter than the vessel treatment range, resulting in infolding of the sealing rings.A re-intervention performed on (b)(6) 2015 successfully resolved the endoleak with the placement of a staple at the level of the sealing collar.As of the date of this report, there have been no additional patient sequelae reported.

Manufacturer Narrative

(b)(4).Device 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: 4933674
• MDR Text Key: 6012827
• Report Number: 3008011247-2015-00073
• 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: 06/23/2015

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: 10/30/2017
• Device Model Number: TV-AB3480-E
• Device Catalogue Number: TV-AB3480-E
• Device Lot Number: FS080714-54
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/23/2015
• Initial Date FDA Received: 07/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2014
• 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
• Treatment: APTUS STAPLE
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR