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

Device Problem Biocompatibility (2886)

Patient Problems Angina (1710); Dyspnea (1816); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446); Tricuspid Valve Insufficiency/ Regurgitation (4453)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, complications from implant of a mechanical heart valve included thrombosis, chest pain, dyspnea, edema, ascites, increased jugular venous pressure, hypotension, reduced click, heart failure, transvalvular leak, and right ventricular ejection fraction from mild to severe.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

The article, "mechanical tricuspid valve thrombosis: a midterm follow-up study", was reviewed.This research article is a retrospective single center experience aimed to report the management and clinical outcomes of patients with mechanical tricuspid valve (tv) thrombosis.St.Jude mechanical prosthetic valve, carbomedics mechanical prosthetic valve (standard), carbomedics mechanical prosthetic valve (orbis), and unknown valve were associated with the study.The article concluded that recurrent thrombosis requiring intervention is a major complication of mechanical tv, which underscores individual-approached therapy and close follow-up.The primary author of this article is maryam shojaeifard, md, department of echocardiography, echocardiography research center, rajaie cardiovascular medical and research center, iran university of medical sciences, tehran, iran.Corresponding author is negar omidi, md, department of echocardiography, rajaie, cardiovascular medical and research center, iran university of medical sciences, rajaei hospital, valiasr avenue, tehran 1996911151, iran, with the corresponding author email: n-omidi@sina.Tums.Ac.Ir.

• Brand Name: SJM® MECHANICAL HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, LLC; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725 ; * 00725
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, LLC; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13599890
• MDR Text Key: 286129310
• Report Number: 3005334138-2022-00156
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: IR
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2022
• 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): Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female