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

Model Number 21AJ-501

Device Problems Backflow (1064); Obstruction of Flow (2423); Biocompatibility (2886)

Patient Problems Aortic Regurgitation (1716); Aortic Valve Stenosis (1717); Dyspnea (1816); Embolism (1829); Thrombosis (2100)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, a patient had stenosis and regurgitation of the aortic valve, with thrombus noted on the valve.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 prosthetic aortic valve thrombosis complicated by an acute coronary syndrome during fibrinolysis" was reviewed.This research article reported a case study on a (b)(6)-year-old man who was implanted with a 21-mm st.Jude mechanical prosthetic aortic valve, 27-mm st.Jude mechanical prosthetic mitral valve and a 29-mm st.Jude attune adjustable tricuspid annular ring.The patient presented to the emergency department 3 years later with progressive dyspnea and orthopnea over the preceding months.The patient¿s medical history was significant for hypertension, hyperlipidemia, severe rheumatic heart disease, symptomatic heart failure, an automatic implantable cardioverter-defibrillator, atrial flutter ablation, chronic kidney disease, and chronic anemia.A transthoracic echocardiogram (tte) showed severe prosthetic aortic valve (av) stenosis along with moderate aortic regurgitation and moderate tricuspid regurgitation.Cardiovascular computed tomography revealed that 1 leaflet of the av was immobile and motion of the second leaflet was severely restricted.Additionally, the patient was found to have thrombosis of the aortic valve prosthesis.The patient was treated with intravenous thrombolysis, but it was complicated by an acute coronary syndrome related to coronary embolism.The physician opted for medical therapy and the patient was successfully managed conservatively with long-term anticoagulation.The article concluded that thrombolysis of prosthetic valve thrombosis(pvt) can be complicated by acute coronary syndrome(acs) through direct embolization.Management should be based on the location, the thrombus burden, and the hemodynamic effects of the embolism.The primary author of this article is joe aoun, md, department of cardiovascular medicine, houston methodist debakey heart and vascular center, houston, texas.The corresponding author is stephen h.Little, director of structural heart, houston methodist hospital system, john s.Dunn chair in clinical cardiovascular research and education, department of cardiology, weill cornell medicine, 6550 fannin street, sm-1801, houston, texas 77030 with the email shlittle@houstonmethodist.Org.

• 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 ; RQ 00725
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725 ; RQ 00725
• Manufacturer Contact: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 11098909
• MDR Text Key: 224796354
• Report Number: 2648612-2020-00139
• 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: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 21AJ-501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/03/2020
• 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: 70 YR