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Table 3 Serious Adverse Events

From: Aortic root surgery with the CARDIOROOT vascular graft: results of a prospective multicenter post-market surveillance study

Serious Adverse Event

Incidence

Cardiac disorder

 Cardiac tamponade*

1 (1.9%)

 Myocardial infarction*

1 (1.9%)

 Pericardial effusion*

1 (1.9%)

 Pericardial effusion/ Sternal dehiscence*

1 (1.9%)

 Ventricular extrasystoles*

1 (1.9%)

Injury, poisoning and procedural complications

 Impaired healing/ Sternal wound healing delay*

1 (1.9%)

 Postoperative thoracic procedure complication*

1 (1.9%)

Infections and infestations

 Pneumonia

1 (1.9%)

 Pericardial infection*

1 (1.9%)

Musculoskeletal and connective tissue disorders

 Synovial cyst

1 (1.9%)

Vascular disorders

 Hemorrhagic shock (death)*

1 (1.9%)

  1. * Deemed by the investigators to be related to the procedure