MAUDE Adverse Event Report: SORIN SIZER, HEART-VALVE, PROSTHESIS

Model Number SORIN MEDICAL

Device Problem Insufficient Information (3190)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888)

Event Type  Injury  

Event Description

Medtronic received information that post - implant, the patient returned to the operating room for chest exploration and hematoma evacuation due to mediastinal bleeding.Hemostasis was achieved prior to chest tube replacement and sternal closure.The patient received a transfusion of one unit of packed red blood cells; the patient received 233 ml of blood via cell saver.No further adverse patient effects were reported.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: SIZER, HEART-VALVE, PROSTHESIS
• Type of Device: SIZER, HEART-VALVE, PROSTHESIS
• Manufacturer (Section D): SORIN
• MDR Report Key: 17528900
• MDR Text Key: 321136849
• Report Number: MW5135829
• Device Sequence Number: 1
• Product Code: DTI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: SORIN MEDICAL
• Patient Sequence Number: 1