| Document Date: 2001-09-10 08:27:32
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City Kennesaw / / Company Primary Repair CryoLife Inc. / Adverse Event Description 1 2 3 CryoLife Inc. / Cerebral Infarction Thromboembolism Thrombosis Other3 / Race AfricanAmerican Asian Caucasian Hispanic Total CryoLife Inc. / CryoLife Inc. / / Country United States / / Event Product Issues / FDA Phase / / IndustryTerm surgical site / prime delivery device / delivery device / adhesive solutions / anastomotic site / hemostatic devices / blood replacement products / control / adhesive delivery device / anastomotic repair site / / MedicalCondition Hemothorax / Cardiac tamponade / allergies / allergic reaction / local tissue necrosis / Aphasia / Acidosis / Urinary retention / Duodenal ulcer / Tissue1 Hemorrhage Infection Inflammatory / transverse aortic arch aneurysm / Cerebral hemorrhage / Pneumothorax / Nausea / Pericardial effusion / Thrombocytopenia / Near syncope / Hemoptysis / Cardiac arrhythmia / Pulmonary / transverse arch/ descending aortic aneurysm / Injury / Encephalopathy / ventricular aneurysm / Angina / Diarrhea / Immune Systemic Allergic Reaction2 Irreversible Morbidity Ischemia Myocardial Infarction Neurological Deficits Organ System Dysfunction/Failure Paraplegia Pleural Effusion Renal Dysfunction/Failure Respiratory Dysfunction/Failure Stroke / Anastomotic pseudoaneurysm / Cerebral Infarction Thromboembolism Thrombosis Other3 / Surgical Adhesive Proposed IFU aneurysm / Renal dysfunction / infectious agents / Back pain / Hypotension / Malnutrition / Abdominal pain / Congestive Heart Failure / Thrombophlebitis / Paraplegia / cerebral infarction / Heart enlargement / Heart block / Hoarseness / Shortness of breath / Dysphagia / Hematuria / Emphysema / Aortic aneurysm / Respiratory dysfunction / Stroke / Vocal cord paralysis / Sexual dysfunction / Ileus / Organ system dysfunction / Atelectasis / thigh and back pain / Fever / Hernia / Seizure / Neck deformity / pain / Myocardial infarction / thoracoabdominal aortic aneurysm / Deep Vein Thrombosis / abdominal aortic aneurysm / Cerebral emboli / infection / irritation / bovine spongiform encephalopathy / Dizziness / Thrombosis / Depression / Anemia / respiratory distress / / MedicalTreatment carotid endarterectomy / Surgery / blood transfusions / skin incision / bypass / / Organization FDA / Intensive Care Unit / / Person Stanford Type / Max Investigators / Teflon / / Position investigator / physician / General / Major / Fisher / / Product areas / BioGlue / / ProvinceOrState Georgia / /
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BioGlue® Surgical Adhesive Proposed IFU Proposed BioGlue Surgical Adhesive