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

Device Problems Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Atrial Fibrillation (1729); Unspecified Infection (1930); Pneumonia (2011); Renal Failure (2041); Sepsis (2067)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, patients implanted with mechanical valves had complications including blood transfusions, wound infection, renal failure, sepsis, pneumonia, stroke, reoperation, and atrial fibrillation.The kind of mechanical valve implanted in the patients experiencing these symptoms was not 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.

Event Description

Reference manufacturing report number: 2648612-2020-00087, 3008452825-2020-00414, 3008452825-2020-00415.The article "outcomes of tissue versus mechanical aortic valve replacement in patients 50 to 70 years of age" was reviewed.This research article is a retrospective single center experience to evaluate the outcomes between mechanical and bioprosthetic valves among patients aged 50 to 70 years undergoing aortic valve replacement (avr).Abbott trifecta, carpentier-edwards perimount, carpentier-edwards magna ease, abbott regent, on-x, and others were associated to the study.There is no allegation of malfunction of the abbott device.The article concluded that in patients age 50 to 70, mechanical avr is associated with improved long-term survival and freedom from repeat aortic valve intervention compared to bioprosthetic valves.The primary author of the article is lauren v.Huckaby, md, division of cardiac surgery, university of pittsburgh medical center with the email: kilica2@upmc.Edu.It was reported in the article that the study was performed between 2010 and 2018.A total of 723 patients were in the study.256 patient were implanted with a mechanical valve and has a median age of 60, with 66.4% of them male.158 of the patient were implanted with a regent valve.467 patients were implanted with a bioprosthetic valve and has a median age of 65, with 60.6% of them male.241 patient were implanted with the trifecta valve.The baseline of patients has a history of diabetes, hypertension, chronic lung disease, kidney disease, immunosuppression, peripheral arterial disease, cerebrovascular disease, family history of cad, heart failure, myocardial infarction, angina, and arrhythmia.Post operative outcome includes: blood transfusion, prolonged ventilation, deep sternal wound infection, acute renal failure, sepsis, pneumonia, permanent stroke, reoperation, and new onset of atrial fibrillation.It was not indicated if these events were associated to an abbott valve.

• Brand Name: REGENT 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: 10417990
• MDR Text Key: 203664274
• Report Number: 2648612-2020-00088
• 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: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 08/11/2020
• 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): Required Intervention
• Patient Age: 65 YR