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Ovation iX Abdominal Stent Graft Systems, REF: TV-AB2080-I… recallZ-2263-2020 · Endologix, Inc. · initiated May 6, 2020

Class I Terminated All recalls posted in June 2020

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 Endologix, 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

A material weakness adjacent to the polymer fill channel may become compromised during pressurization with liquid polymer. Polymer leaks may occur during implantation of abdominal stent graft system. Clinical events related to polymer leaks may be systemic and/or aneurysm related.

FDA root cause category: Process control

What the company is doing

On 05/06/20, "Urgent Medical Device Correction notices" were distributed to customers via person/mail/email. These notices reaffirmed treatment recommendations for patients provided in the previously distributed Urgent Field Safety Notice, dated 09/26/2018 that were mailed on 09/27/18. Safety Update: Treatment of a Patient with Polymer Leak - Patient Reaction During the polymer injection step of the procedure, systemic hypotension may indicate that a polymer leak is occurring. Blood pressure monitoring during polymer fill may assist in early identification of a potential polymer leak. In the absence of other obvious diagnoses causing sudden hypotension during polymer fill, firm recommends that a hypersensitivity reaction (an anaphylactoid response) to intravascular polymer leak be considered a probable diagnosis. Patients with a polymer leak should undergo immediate treatment for a potential severe hypersensitivity response in accordance with institutional protocols (e.g., intravascular fluids, antihistamines, corticosteroids, epinephrine). In addition to systemic hypotension, device related findings that are indicative of a polymer leak include rapid emptying of the fill polymer syringe, and incomplete filling of the polymer channels. Safety Update: Treatment of a Patient with Polymer Leak - Aneurysm Management Aneurysm related complications that may occur due to polymer leak should be treated with standard endovascular techniques at the physician's discretion, utilizing the ancillary equipment listed in the Instructions for Use (IFU), or an open surgical approach. The specific treatment will be dependent on the extent and location of incomplete filling of the polymer rings and the associated clinical findings. In respect of intra-operative Type 1a endoleaks resulting from polymer leak, there were two main treatment strategies: (1) conservative management (in the cases of small endoleaks expected to resolve spontaneously) or (2) the use of balloon expand

Recall details

Recall number
Z-2263-2020
Recall class
Class I (most serious)
Status
Terminated
Initiated by the company
May 6, 2020
Posted by the FDA
Jun 11, 2020
Recalling firm
Endologix, Inc.
Quantity
9156
Product code
MIH
FDA submissions
P120006
Distribution
Worldwide DIstribution: U.S (nationwide).: PA, AZ, NY, FL, HI, CA, OR, IL, MS, AR, WI, KY, TX, TN, MO, NJ, MA, MT, VA, MI, CO, WV, NC, NH, NV, CT, ME, WY, OH, OK, IN, UT, AL, WA, GA, SC, KS, LA, NM, MD, DC, NE, SD, RI, IA, VT, ND. and Countries of:: Argentina, Australia, Chile, Hong Kong, Japan, Malaysia, Mexico, New Zealand, Taiwan, Thailand, Canada, Austria, Belgium, Cyprus, Czech Republic, Germany, Hungary, Ireland, Italy, Switzerland, Luxembourg, Netherlands, Poland, Portugal, Romania, Spain, Sweden, and United Kingdom

Product description

Ovation iX Abdominal Stent Graft Systems, REF: TV-AB2080-I, TV-AB2080-J, TV-AB2380-I, TV-AB2380-J, TV-AB2680-I, TV-AB2680-J, TV-AB2980-I, TV-AB2980-J, TV-AB3480-I, TV-AB3480-J

Code information (models, lots, serial numbers)

All Lot and Serial Numbers not yet implanted

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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