MAUDE Adverse Event Report: MITRAL VALVE REPLACEMENT; PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED

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

Patient Problem Thrombosis/Thrombus (4440)

Event Type  Death  

Event Description

My son had mitral valve replaced on (b)(6) 2021.He never had his coumadin level stabilize.It was usually a bit low.The last 2 weeks it was above the normal range; and 21 days prior to his passing, had his second covid vaccine.On the (b)(6) he passed away from a blood clot.I'm not sure if any of this adds up to a report.But i felt like i needed to put in a few words.He was an organ donor.(b)(6) organization did take him to (b)(6) to do that donation, and (b)(6) coroner office handle his official documents and information.Fda safety report id# (b)(4).

• Brand Name: MITRAL VALVE REPLACEMENT
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• MDR Report Key: 13358444
• MDR Text Key: 284523723
• Report Number: MW5106963
• Device Sequence Number: 1
• Product Code: NPU
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 01/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: NOT SURE
• Patient Outcome(s): Death
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Race: White