MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC HEART-VALVE, NON-ALLOGRAFT TISSUE

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

Patient Problems Fall (1848); Nausea (1970); Dizziness (2194); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

Medtronic received information that one day after an aortic valve replacement the patient developed a sudden episode of nausea and dizziness, resulting in a fall while walking with a nurse.A computed tomography (ct) scan of the head showed cerebellar stroke of unclear age, the patient continued to have dizziness and unsteadiness.In the afternoon on the second post-operative day, the patient fell a second time, prompting another head ct.This showed left cerebellar infarct.The patient was transferred to the intensive care unit for further management.No further adverse patient effects reported.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC
• MDR Report Key: 17535185
• MDR Text Key: 321147187
• Report Number: MW5142084
• 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: 12/04/2017

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