MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC SAPIEN 3 VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Perforation (2001)

Event Type  Death  

Event Description

Medtronic received information that following the implant of a transcatheter bioprosthetic valve, an edwards sapien 3 valve was planned to be implanted, however, the aorta became perforated by the edwards dilator and the subsequently patient died.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: SAPIEN 3 VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC
• MDR Report Key: 17530071
• MDR Text Key: 321038998
• Report Number: MW5136991
• Device Sequence Number: 1
• Product Code: NPT
• 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: 06/14/2017

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
• Patient Sequence Number: 1