MAUDE Adverse Event Report: EDWARDS MAGNA; AORTIC VALVE 23MM

Model Number MAGNA

Device Problem Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Death (1802); Fever (1858); Test Result (2695)

Event Date 09/02/2014

Event Type  Death  

Event Description

Patient received a 21 mm carpentier edwards magna bioprosthetic valve prosthesis on (b)(6) 2013.He subsequently presented with fever and underwent empiric treatment for endocarditis beginning (b)(6) 2013.The diagnosis remained elusive until (b)(6) 2014 when peripheral blood cultures and cultures from a tissue biopsy from an embolus to the skin demonstrated nocardia.A subsequent operation was performed to replace the prosthesis in which the patient did not survive.

• Brand Name: MAGNA
• Type of Device: AORTIC VALVE 23MM
• Manufacturer (Section D): EDWARDS
• MDR Report Key: 4296525
• MDR Text Key: 16635005
• Report Number: MW5039350
• Device Sequence Number: 1
• Product Code: LWR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/23/2016
• Device Model Number: MAGNA
• Device Catalogue Number: 3000TFX
• Device Lot Number: 3490188
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/28/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 63 YR