PMA P120006S036

Device: Ovation iX Abdominal Stent Graft System
Applicant: Endologix, LLC
PMA number: P120006
Supplement: S036
Product code: MIH
Decision date: 2020-07-09
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: Approval for updating the IFU with the following language:Polymer leaks are a unique potential risk of the Ovation device platform that have been reported post-market. The complications of polymer leakage in to the vasculature have ranged from transient hypotension to severe life-threatening anaphylactoid reactions, tissue necrosis and death. When polymer leaks occur, underfilling of the Ovation iX sealing rings have led to intraoperative Type Ia endoleaks that have required additional therapy. The risk of polymer leak should be carefully considered along with the risks associated with alternative treatment options when making personalized treatment decisions for those individuals who fall within the indicated patient population as defined by the Instructions for Use. This updated language was agreed upon as part of the mitigation strategy of the Class I Recall of the Ovation iX.

Current openFDA PMA Record#

Device: Ovation iX Abdominal Stent Graft System
Applicant: Endologix, LLC
PMA number: P120006
Supplement: S036
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2020-07-09
Decision code: APPR
Date received: 2020-06-09
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for updating the IFU with the following language:Polymer leaks are a unique potential risk of the Ovation device platform that have been reported post-market. The complications of polymer leakage in to the vasculature have ranged from transient hypotension to severe life-threatening anaphylactoid reactions, tissue necrosis and death. When polymer leaks occur, underfilling of the Ovation iX sealing rings have led to intraoperative Type Ia endoleaks that have required additional therapy. The risk of polymer leak should be carefully considered along with the risks associated with alternative treatment options when making personalized treatment decisions for those individuals who fall within the indicated patient population as defined by the Instructions for Use. This updated language was agreed upon as part of the mitigation strategy of the Class I Recall of the Ovation iX.