MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. SJM REGENT HEART VALVE W/FLEX CUFF; HEART-VALVE, MECHANICAL

Model Number 19AGFN-756

Device Problems Gradient Increase (1270); Obstruction of Flow (2423); Biocompatibility (2886)

Patient Problems Myocardial Infarction (1969); Pulmonary Edema (2020); Thrombus (2101)

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, "a rare case of partial aortic mechanical valve thrombosis with intact mitral mechanical valve presenting with st-elevation myocardial infarction patients", was reviewed.This research article reported a (b)(6)-year-old female, with a history of hypertension, diabetes, hyperlipidemia, heart failure, chronic obstructive pulmonary disease, hypothyroidism, atrial fibrillation and rheumatic mitral valve disease was implanted with a 19mm sjm regent series aortic valve and a 27mm masters series mitral valve in 2016.The patient presented to the hospital with st-segment elevation myocardial infarction(stemi) and pulmonary edema due to mechanical aortic valve prosthesis (mavp) thrombosis.An echocardiogram revealed elevated gradients and fluoroscopy revealed normal motion on the leaflets of the mechanical mitral prosthesis and only one mobile leaflet in the mechanical aortic valve prosthesis(mpav).A transesophageal echocardiogram showed thrombus within the prosthetic aortic valve prolapsing into the left ventricular outflow tract as well as toward the ascending aorta and flow across the valve was limited.The patient was discharged in a stable condition on a therapeutic dose of warfarin, aspirin (81 mg), and plans to follow with her cardio thoracic surgeon for evaluation of reoperation.The article concluded that it is important to include valve thrombosis in the differential in the presence of mechanical prosthesis and stemi, especially in the setting of heart failure and/or angiographic characteristics compatible with large thrombus burden.The primary author of the article is mazin o.Khalid, mbbs, department of cardiology, maimonides medical center with the email dr.Mazinkhalid@gmail.Com.

Manufacturer Narrative

As reported in a research article, a patient was implanted with a 19mm sjm regent series valve and a 27mm masters series valve in 2016.An event of st-segment elevation myocardial infarction, pulmonary edema, thrombus, elevated gradient, immobile leaflets, and obstruction of flow was 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 REGENT HEART VALVE W/FLEX CUFF
• 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: 10924711
• MDR Text Key: 218927357
• Report Number: 2648612-2020-00129
• 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: health professional,literatur
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 19AGFN-756
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR