MAUDE Adverse Event Report: EDWARDS LIFESCIENCES AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number SAPIEN VALVE

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Perforation of Vessels (2135)

Event Type  Injury  

Event Description

Medtronic received information that prior to the implant of a transcatheter bioprosthetic valve, an edwards sapien valve was attempted to be implanted but was unable to access the vessel.The transcatheter bioprosthetic valve was attempted and still was unable to access the vessel.A dissection of the left femoral artery was reported and required vascular surgery to repair the vessel.It is unknown when the vessel dissected.It was reported that the delivery catheter system (dcs) did not make it to the level of the dissection, however the edwards valve did.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: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES
• MDR Report Key: 17535690
• MDR Text Key: 321135659
• Report Number: MW5142585
• 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: 01/22/2018

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: SAPIEN VALVE
• Patient Sequence Number: 1