System, Endovascular Graft, Aortic Aneurysm Treatment
Basic Information
- Device Name
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Trade Name
- Ovation iX Abdominal Stent Graft System
- PMA Number
- P120006
- Supplement Number
- S036
- Device Class
- FDA Class 3
- Product Code
- MIH
- Generic Name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- July 9, 2020
- Date Received
- June 9, 2020
- Supplement Type
- Special (Immediate Track)
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MIH | System, Endovascular Graft, Aortic Aneurysm Treatment | FDA class 3 | Unknown |