MAUDE Adverse Event Report: MEDTRONIC MEDTRONIC; ARTIFICIAL HEART VALVE

Model Number 25MG-J-503

Device Problems Break (1069); Detachment Of Device Component (1104); Material Disintegration (1177)

Patient Problems Chest Pain (1776); Death (1802); Hemorrhage/Bleeding (1888); Suffocation (2088)

Event Date 02/17/2013

Event Type  Death  

Event Description

The patient had a heart valve implanted in the (b)(6) which lasted for 15 years.On (b)(6) 2010, it was replaced with a new medtronic metal heart valve; also a tricuspid valve (tissue valve) was implanted by (b)(6), cardiac and vascular surgeon from (b)(6).The tissue valve failed after 10 months.It was too early for the patient to get another surgery, so the doctors waited one an half years for the open heart surgery.On (b)(6) 2013, the tissue valve was replaced with a new one.On (b)(6) 2013, the patient could not breathe and had lots of pain.The pt's husband called 911 and she was taken to the hospital.The medtronic metal heart valve disintegrated inside.All four hinges broke an both doors detached.Half an hour later , the blood pooled inside the lungs, which suffocated her and the patient died.Autopsy was done and cause of the death was the defective valve.The patient's body was sent back to the (b)(6).The pt's husband preserves the valve and it is available for evaluation.Pt's husband provided a goggle search to obtain additional information concerning his wife; "(b)(6)".

• Brand Name: MEDTRONIC
• Type of Device: ARTIFICIAL HEART VALVE
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 4475802
• MDR Text Key: 5499831
• Report Number: MW5040512
• Device Sequence Number: 1
• Product Code: LWQ
• 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: 01/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 25MG-J-503
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Treatment: TRISCUSPID TISSUE VALVE
• Patient Outcome(s): Death
• Patient Age: 38 YR
• Patient Weight: 39