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

Model Number 31MJ-501

Device Problem Obstruction of Flow (2423)

Patient Problems Dyspnea (1816); Thrombus (2101)

Event Date 01/06/2021

Event Type  Injury  

Manufacturer Narrative

An event of endocarditis, dyspnea, thrombus, and an immobilized leaflet was reported.A more comprehensive assessment could not be performed as 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

On an unknown date, a 31mm sjm masters series mechanical heart valve was implanted.On an unknown date, the patient experienced endocarditis and was on immunosuppression.For a few months, the patient reportedly did well, but had some inr fluctuations and then developed dyspnea.Echocardiogram was performed, which showed thrombus's in the atrium and one immobilized leaflet.On (b)(6) 2021, the patient was admitted to the hospital for thrombus removal operation.During the procedure, the blood clot was removed and the physician wanted to rotate the valve.However, the valve was not rotated.The patient was reported to be in stable condition.

• Brand Name: SJM MASTERS SERIES 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 ; * 00725
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725 ; * 00725
• Manufacturer Contact: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 11247542
• MDR Text Key: 229324067
• Report Number: 2648612-2021-00006
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 31MJ-501
• Device Catalogue Number: 31MJ-501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 44 YR