MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC SAPIEN 3 ULTRA VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 26 SAPIEN 3 ULTRA VALVE PLACED 23FEB22 AT ALEXIAN BROTHERS HOSPITAL.

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Unspecified Infection (1930)

Event Date 05/13/2022

Event Type  Injury  

Event Description

Early (b)(6) 2022.Tee positive vegetation with abscess.Blood cultures positive strep sanguinis.(b)(6) 2022 - had avr procedure using 23 resilia aortic valve conduit.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: SAPIEN 3 ULTRA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC
• MDR Report Key: 17528146
• MDR Text Key: 321134295
• Report Number: MW5135077
• Device Sequence Number: 1
• Product Code: LWR
• 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: 07/05/2022

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: 26 SAPIEN 3 ULTRA VALVE PLACED 23FEB22 AT ALEXIAN BROTHERS HOSPITAL.
• Patient Sequence Number: 1