US Pivotal Clinical Study of the Adient Absorbable Filter for the Prevention of Pulmonary Embolism

INCLUSION CRITERIA: Aged 18 years or older Willing to comply with the specified follow-up requirements including contrast enhanced CTs for the 9-month duration of the study For female subjects of childbearing potential: a negative pregnancy test within 48 hours prior to the implantation procedure For the prophylactic cohort, high risk VTE denoted by either: Caprini score \> 8 for surgical ICU, Parvizi score ≥ 150 for TKA (total knee replacement), ISS score ≥ 24 for trauma. For the therapeutic cohort, documented VTE per the following: Pulmonary thromboembolism when anticoagulants are contraindicated, Failure of anticoagulant therapy in thromboembolic diseases, Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced. Requirement of temporary PE protection (8 weeks) based on clinical judgment Fully informed subject or caretaker consent having executed an Institutional Review Board (IRB) or approved informed consent. EXCLUSION CRITERIA: Expected high VTE risk to extend beyond 8 weeks. Vena cava filter currently implanted History of abdominal or pelvic radiation therapy Previous IVC filter placement/retrieval within 6 months prior to randomization Confirmed positive blood cultures within the last 48 hours if there is bacteremia Known sensitivity to radiographic contrast medium that cannot be adequately prophylactically pre-medicated Known allergy or intolerance to IVC filter materials (i.e. PDSII absorbable suture) Pregnant, lactating, or plans to become pregnant during investigation follow-up period Renal insufficiency (GFR \< 60) or requiring renal replacement therapy IVC effective diameter (D) \<16 mm or \>28 mm anywhere within L1-L4, D = √(AP\*Lat) Less than 7cm from inferior-most renal vein to the iliac vein confluence Duplication of the IVC Any thrombus or occlusion in IVC on pre-procedural CT cavogram Life expectancy of \< 12 months Simultaneous participation in another investigative drug or device trial that has not reached its primary endpoint Other co-morbid condition that, in the opinion of the Investigator, could limit the subject's ability to participate in or would affect the scientific integrity of the study Previously enrolled in a clinical investigation of the Adient filter. For Roll In, patient has advanced heart failure or recent (6 weeks) myocardial infarction. - - - Advanced heart failure is defined by NYHA class IV or AHA/ACC/HFSA stage D or LVEF \< 40%. Subjects with MI diagnosed with ECG alone without MI history and symptoms are not excluded.