Events

Recall of TriVascular Fill Polymer Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Trivascular, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    63586
  • Event Risk Class
    Class 2
  • Event Number
    Z-0288-2013
  • Event Initiated Date
    2012-10-19
  • Event Date Posted
    2012-11-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-12-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114263
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, endovascular graft, aortic aneurysm treatment - Product Code MIH
  • Reason
    Selected lots of the fill polymer kit (european model number: tvfp14- b) in european distributor inventory only that potentially contain leaking stopcocks due to possible cracks in the stopcock component. trivascular indicated that these fill polymer kits are for use with the ovation or ovation prime abdominal stent graft systems that may display leaks upon initiation of mix but prior to use in.
  • Action
    Trivascular sent an Urgent Field Safety Notice letter dated October 19, 2012 to all affect consignees. A verbal (telephone) communication was also initiated. The forms communication identified the affected product, problem and actions to be taken. Consignees were instructed to immediately quarantine and return affected products. A return response form was included for consignees to complete and returned via the e-mail address or fax number provided. Consignees were instructed to further notify its (sub-level) consignees, and have them return affected product directly to the recalling firm. For questions call 1-707-543-8732.

Device

TriVascular Fill Polymer Kit
  • Model / Serial
    The following lot numbers are in distributor inventory in Europe: FF121211-04, FF010912-01, FF013112-01, FF020912-01, FF022212-03, FF022912-01, FF040412-01,  FF051012-01
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US Nationwide and the countries of Belgium, Cyprus, Italy, Spain, Switzerland and Turkey. TriVascular stated that no purchased devices are in hospital inventory in Europe or the U.S.
  • Product Description
    TriVascular brand Fill Polymer Kit, Endovascular Graft, Aneurysm Treatment System, European Model Number: TVFP14-B, (in European distributor inventory only); || PRODUCT Usage: || The TriVascular Ovation Abdominal Stent Graft System is indicated in subjects diagnosed with an aneurysm in the abdominal aorta having vascular morphology suitable for endovascular repair, including: (1) Adequate iliac/femoral access compatible with vascular access techniques, devices, and/or accessories, (2) Non-aneurysmal proximal aortic neck: - with a length of at least 7 mm proximal to the aneurysm, - with an inner wall diameter of no less than 16 mm and no greater than 30 mm, and - with an aortic angle of d 60 degrees if proximal neck is e 10 mm and d 45 degrees if proximal neck is < 10 mm, (3) Non-aneurysmal distal iliac landing zone: - with a length of at least 10 mm, - with an inner wall diameter of no less than 8 mm and no greater than 20 mm
  • Manufacturer
    Trivascular, Inc

Manufacturer

Trivascular, Inc
  • Manufacturer Address
    Trivascular, Inc, 3910 Brickway Blvd, Santa Rosa CA 95403
  • Manufacturer Parent Company (2017)
    Endologix Inc.
  • Source
    USFDA