MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. SJM MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL

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

Patient Problem Corneal Pannus (1447)

Event Type  Injury  

Event Description

The following information was obtained from the 9th annual meeting of the (b)(6) society for heart valve disease, titled: "a case of intermittent aortic regurgitation due to prosthetic valve dysfunction".In (b)(6) 2001, a 19mm abbott mechanical valve was implanted in the aortic position and a 29mm mosaic valve was implanted in the mitral position for mitral valve stenosis and insufficiency and tricuspid valve insufficiency.In (b)(6) 2017, the patient experienced edema in the legs and orthopnea which was attributed to aortic valve dysfunction so the aortic valve was replaced."a pannus formation of 15 mm was observed in the aorto-mitral curtain part on the left side of the aortic valve".Detailed information could not be obtained about reoperation.

Manufacturer Narrative

An event of edema in the legs, orthopnea, regurgitation and pannus 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 MECHANICAL HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• MDR Report Key: 8410670
• MDR Text Key: 138498486
• Report Number: 2648612-2019-00018
• 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: literature
• Type of Report: Initial,Followup
• Report Date: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2019
• 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: 04/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR