MAUDE Adverse Event Report: ST. JUDE MEDICAL, BRASIL LTDA. SJM HEART VALVE (UNKNOWN); TRANSCATHETER SEPTAL OCCLUDER

Model Number CVD0025

Device Problem Biocompatibility (2886)

Patient Problem Endocarditis (1834)

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

On an unknown date a abbott mechanical valve was implanted.In (b)(6) 2019 the valve was explanted due to endocarditis.The patient was reported to be recovering post procedure.Additional information was requested but cannot be obtained.

Manufacturer Narrative

Additional information: h3, h6, h10.An event of valve explant due to endocarditis was reported.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: SJM HEART VALVE (UNKNOWN)
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ST. JUDE MEDICAL, BRASIL LTDA.; rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• MDR Report Key: 9739809
• MDR Text Key: 180527832
• Report Number: 3001883144-2020-00009
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CVD0025
• Device Catalogue Number: CVD0025
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/29/2020
• Initial Date FDA Received: 02/21/2020
• Supplement Dates Manufacturer Received: 02/23/2020
• Supplement Dates FDA Received: 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention