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

Device Problem Biocompatibility (2886)

Patient Problems Angina (1710); Atrial Fibrillation (1729); Stroke/CVA (1770); Transient Ischemic Attack (2109); Thromboembolism (2654); Thrombosis/Thrombus (4440)

Event Date 04/09/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The article, "characteristic localization patterns of thrombus on various brands of bileaflet mitral mechanical heart valves as assessed by three-dimensional transesophageal echocardiography and their relationship with thromboembolism." was reviewed.This research article is a retrospective single center experience to clarify whether thrombus tended to display different localization patterns among most frequently implanted bileafet mitral mechanical prosthetic heart valves(mphvs).Sjm mechanical heart valve (abbott), carbomedics((b)(4)) medtronic ats valve(medtronic) and sorin bicarbon valves were associated with the study.The article concluded that thrombus can be displayed in distinct locations in several types of bileafet mechanical valves due to different design, hinge and pivot mechanisms, which can be complicated with thromboembolic events.Classification and describing the thrombus localization patterns that are frequently encountered in clinical practice will help the clinicians during the patients¿ follow-up with prosthetic valve thrombosis(pvt).The primary and correspondence author of the article is munevver sari, department of cardiology, kosuyolu kartal heart training and research hospital, denizer caddesi, cevizli kavsagi, kartal, 34865 istanbul, turkey with the corresponding email:benmsr@hotmail.Com.

Manufacturer Narrative

Additional information for: g3, g6, h2, h6, and h10.As reported in a research article, 265 patients were diagnosed with bileaflet mechanical mitral prosthetic valve thrombosis from january 2009 to december 2019; 150 patients were implanted with an sjm mechanical heart valve in the mitral position.Events of prosthetic valve thrombosis, stroke, transient ischemic attack, coronary embolism, peripheral embolism, renal artery embolism, brachial artery embolism, angina pectoris, pannus, perivalvular leak, and atrial fibrillation were reported.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.

• 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: 11904833
• MDR Text Key: 266275285
• Report Number: 2648612-2021-00057
• 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: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2021
• 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: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR