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U.S. Department of Health and Human Services

Class 1 Device Recall Ovation iX Abdominal Stent Graft System

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 Class 1 Device Recall Ovation iX Abdominal Stent Graft Systemsee related information
Date Initiated by FirmMay 06, 2020
Date PostedJune 11, 2020
Recall Status1 Terminated 3 on May 03, 2024
Recall NumberZ-2263-2020
Recall Event ID 85480
PMA NumberP120006 
Product Classification System, endovascular graft, aortic aneurysm treatment - Product Code MIH
ProductOvation 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 All Lot and Serial Numbers not yet implanted
Recalling Firm/
Manufacturer		 Endologix, Inc.
3910 Brickway Blvd
Santa Rosa CA 95403-1070
For Additional Information Contact
707-543-8800
Manufacturer Reason
for Recall		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 Determined
Cause 2		Process control
ActionOn 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
Quantity in Commerce9156
DistributionWorldwide 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
Total Product Life CycleTPLC Device Report
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.
PMA DatabasePMAs with Product Code = MIH
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