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 Perivalvular Leak (1457); Biocompatibility (2886)

Patient Problems Endocarditis (1834); Hemolysis (1886); Intracranial Hemorrhage (1891); Valvular Insufficiency/ Regurgitation (4449)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Related manufacturing reference number : 2648612-2021-00032.The article, "effectiveness of annuloplasty and enlargement by manouguian method" was reviewed.The research article presents a case study of a (b)(6) year old woman, who experienced heart surgery three times including a double valve replacement (dvr), mechanical heart valve (mhv) sjm 21mm in aortic position and mechanical heart valve (mhv) sjm 27mm in mitral position) and tricuspid valve replacement (tvr) since 20s.The patient suffered cerebellar hemorrhage about a year ago and infectious endocarditis was diagnosed after that.Paravalvular leak (pvl) and severe hemolysis occurred as well.Both valves had been detached from annulus due to the annulus tissue infection.Aortic and roof of the left atrium via both annulus were incised by manouguian method.Debridement was performed for infected annulus tissue.From the roof of the left atrium to mitral annulus were conducted enlarged reconstruction by bovine pericardium.Then composite graft was created and sutured by bentall procedure.Enterococcus faecalis was detected by blood culture.Antibiotic drip was administered for 6 weeks.The patient was discharged from the hospital on (post-operative day)pod 48.The cardiac function was periodically checked by ucg and no anomalies has been observed so far.

Manufacturer Narrative

Additional information for: g3, g6, h2, h6, and h10 as reported in a research article, a patient had a double valve replacement with a sjm masters series mechanical heart valves implanted in both the aortic and mitral position; an event of cerebellar hemorrhage, endocarditis, paravalvular leak, hemolysis, and valve explant.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 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
• MDR Report Key: 11566609
• MDR Text Key: 242181904
• Report Number: 2648612-2021-00031
• 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: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2021
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR