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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Endocarditis (1834)

Event Date 08/27/2020

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, complications from having a mechanical valve implanted included reoperation, infective endocarditis, and stroke.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 "survival and long-term outcomes after concomitant mitral and aortic valve replacement in patients with rheumatic heart disease" published on 27 august 2020 was reviewed.This research article is a retrospective single center experience to study the survival rate, early and late mortality and major adverse cardiac and cerebrovascular events (macce) in patients undergoing double valve replacement (dvr) for rheumatic heart disease, with various generations of prosthetic valves ranging from ball in cage to bileaflet prosthesis and tilting disc valves.Chitra heart valve prosthesis, medtronic hall valve, abbott mechanical heart valve, starr¿edwards valve were associated to the study.There is no allegation of malfunction of the abbott device.The article concluded that patients can have an improved functional status following dvr surgery, with good rates of freedom from re-operation and macce.The primary author of the article is vivek velayudhan pillai, md of department of cardiovascular and thoracic surgery, sree chitra tirunal institute for medical sciences and technology, trivandrum 695011, india with the corresponding email drvivekpillai@yahoo.Co.In.

• 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 ; 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: 10722974
• MDR Text Key: 212703443
• Report Number: 2648612-2020-00106
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• 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: 10/19/2020
• 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: 37 YR