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Ovation Prime Abdominal Stent Graft System - 29mm Aortic… recallZ-0125-2015 · Trivascular, Inc · initiated Sep 20, 2014

Class I Terminated All recalls posted in November 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Trivascular, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-0125-2015
Recall class
Class I (most serious)
Status
Terminated
Initiated by the company
Sep 20, 2014
Posted by the FDA
Nov 3, 2014
Recalling firm
Trivascular, Inc
Quantity
0 Devices
Product code
MIH
FDA submissions
P120006
Distribution
International Distribution Only -- Canada, Turkey, Austria, Ireland, Belgium, Italy, Switzerland, Spain, France, and Cyprus.

Product description

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 (models, lots, serial numbers)

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"

Other devices under the same FDA submission

42 devices cleared under P120006 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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