MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. (CS-WOODRIDGE) SJM MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL

Device Problems Obstruction of Flow (2423); Biocompatibility (2886)

Patient Problems Corneal Pannus (1447); Aortic Valve Stenosis (1717); Calcium Deposits/Calcification (1758)

Event Date 03/03/2015

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Reference manufacturing report number 3008452825-2020-00162.On an unknown date, an abbott mechanical aortic valve was implanted.On (b)(6) 2015, mechanical valve was explanted due to stenosis that led to obstruction of flow and was replaced with a 21mm trifecta valve.Pannus was observed on the mechanical valve and calcification was also observed on the native aorta at left sinus level just above the left common trunk.

Manufacturer Narrative

An event of dyspnea and syncope with stenosis and pannus noted on the valve 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.

Event Description

Reference manufacturing report 3008452825-2020-00162.In 1992, an abbott mechanical aortic valve was implanted.In (b)(6) 2015, the patient presented symptoms of dyspnea and syncope.On (b)(6) 2015, mechanical valve was explanted due to stenosis and pannus and was replaced with a 21mm trifecta valve.Pannus was observed on the mechanical valve and calcification was also observed on the native aorta at left sinus level just above the left common trunk.

• Brand Name: SJM MECHANICAL HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. (CS-WOODRIDGE); 177 east county road b; st. paul MN 55117
• MDR Report Key: 9886653
• MDR Text Key: 187560487
• Report Number: 3007113487-2020-00005
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 21MM TRIFECTA VALVE
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 68 YR