MAUDE Adverse Event Report: EDWARDS LIFESCIENCES VENOUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Device Problem Insufficient Information (3190)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Death  

Event Description

Medtronic received information that a patient died in surgery on (b)(6) 2011 due to retroperitoneal bleed caused by a venous cannula (manufacturer edwards lifescience).This was during the attempted implant of a medtronic apico-aortic conduit.The surgeon explained this was not related to the medtronic product used.N/a.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: VENOUS CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES
• MDR Report Key: 17527667
• MDR Text Key: 321039154
• Report Number: MW5134599
• Device Sequence Number: 1
• Product Code: DWF
• 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: 12/06/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1