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

Model Number TV-AB2980-D

Device Problems Excess Flow or Over-Infusion (1311); Nonstandard Device (1420); Premature Activation (1484)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 09/04/2014

Event Type  malfunction  

Event Description

A 29mm ovation prime abdominal stent graft system was implanted in the patient during endovascular repair of an abdominal aortic aneurysm.The mid-crown of the proximal stent was inadvertently deployed prior to the retraction of the delivery system outer sheath.Significant tension and manipulation of the delivery system was required to un-sheath and position the stent graft.During polymer fill, the fill polymer syringe emptied completely and the patient experienced transient hypotension which was successfully treated in accordance with the product ifu.The stent graft did not fill with polymer; contrast was injected into the lumen of the stent graft to visualize the ipsilateral and contralateral legs of the aortic body graft to facilitate accurate placement of the iliac limbs.The aneurysm was successfully excluded and there were no additional patient sequelae.

Manufacturer Narrative

Based upon this event and an increase in complaints related to incomplete intraoperative polymer fill of the ovation prime 29mm aortic body stent graft, trivascular initiated a field safety corrective action on september 20, 2014 to retrieve from distributor inventory (b)(4) affected devices manufactured within the same time period as the device for this event.No devices in the united states were subject to this corrective action.

• 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: tim doolin ; 3910 brickway blvd.; santa rosa, CA 95403 ; 7075438732
• MDR Report Key: 4141064
• MDR Text Key: 4949315
• Report Number: 3008011247-2014-00076
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P120006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 09/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/30/2016
• Device Model Number: TV-AB2980-D
• Device Catalogue Number: TV-AB2980-D
• Device Lot Number: FS042914-35
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/04/2014
• Initial Date FDA Received: 10/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: REPORTED - TBA
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR