Ovation iX Abdominal Stent Graft Systems, REF: TV-AB2080-I, TV-AB2080-J, TV-AB2380-I, TV-AB2380-J, TV-AB2680-I, TV-AB268

FDA device recall Z-2263-2020 · posted 2020-06-11 · Terminated

Recall details

Recalling firm

Endologix, Inc.

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.

Action taken

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

Root cause

Process control

Status

Terminated

Product code

MIH

Quantity affected

9156

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, M

Date initiated

2020-05-06

Date posted

2020-06-11

Date terminated

2024-05-03

Location

Santa Rosa, CA