Date Initiated by Firm | September 20, 2014 |
Date Posted | November 03, 2014 |
Recall Status1 |
Terminated 3 on December 04, 2014 |
Recall Number | Z-0125-2015 |
Recall Event ID |
69326 |
PMA Number | P120006 |
Product Classification |
System, endovascular graft, aortic aneurysm treatment - Product Code MIH
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Product | Ovation Prime Abdominal Stent Graft System - 29mm Aortic Body stent grafts.
The TriVascular Ovation Prime Abdominal Stent Graft System is a low-profile endovascular device delivered via catheter to treat descending abdominal aortic aneurysms (AAAs). |
Code Information |
The devices subject to this action are labeled for distribution outside of the United States; therefore, no UDI is on the device label or package. Model Number: TV-AB2980-D Lot Numbers: FS031814-11 FS052214-22 FS052814-36 FS040414-21 FS050614-56 FS040714-53 FS040514-02 FS042614-05 FS050614-53 FS032614-46 FS050214-27 FS050314-12 FS052214-48 FS052214-53 FS031814-44 FS031814-49 FS032714-04 FS032714-20 FS040414-30 FS040514-08 FS050114-01 FS050114-08 FS050514-18 FS050514-27 FS050614-54 FS050614-55 FS051914-32 FS051914-34 Expiry dates ranging "May-17" through "Jun-17" |
Recalling Firm/ Manufacturer |
Trivascular, Inc 3910 Brickway Blvd Santa Rosa CA 95403
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For Additional Information Contact | Tim Doolin 707-543-8732 |
Manufacturer Reason for Recall | TriVascular has identified select lots of Ovation Prime 29mm Aortic Body stent grafts that may be associated with rapid emptying of the fill polymer syringe when it is connected to the Autoinjector during the fill polymer injection step of the primary implant procedure. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | Urgent Field Safety Notice letter was sent to all consignees on 9/19/14 via trackable mail system. Users are notified that TriVascular has identified select lots of Ovation Prime 29mm Aortic Body stent grafts that may be associated with rapid emptying of the fill polymer syringe when it is connected to the Autoinjector during the fill polymer injection step of the primary implant procedure. |
Quantity in Commerce | 0 Devices |
Distribution | International Distribution Only -- Canada, Turkey, Austria, Ireland, Belgium, Italy, Switzerland, Spain, France, and Cyprus. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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PMA Database | PMAs with Product Code = MIH
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