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); Mitral Valve Stenosis (1965); Thrombosis/Thrombus (4440); Heart Block (4444); Heart Failure/Congestive Heart Failure (4446)

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, "predictors of survival in paediatric mitral valve replacement" was reviewed.This research article is a retrospective single center experience to identify the predictors of death and of reintervention after mitral valve replacement (mvr) in children.Perimunt magna ease, melody stented bovine jugular vein graft, hancock ii, hancock valved conduit, carbomedics, bjork-shiley, medronic ats, st, jude medical mechanical valve and ionescu-shiley valves were associated with the study.There is no allegation of malfunction of the abbott device.The article concluded that mvr is a viable strategy in children with unrepairable mitral valve disease.The primary and correspondence author of the article is gianluca brancaccio, department of pediatric cardiac surgery, bambino gesu children¿s hospital, rome, italy with the corresponding email: gianluca.Brancaccio@opbg.Net.

Manufacturer Narrative

As reported in a research article, 115 patients underwent mitral valve replacement due to mitral stenosis and/or mitral regurgitation, between 1 july 1982 and 31 december 2019, with a perimunt magna ease, melody stented bovine jugular vein graft, hancock ii, hancock valved conduit, carbomedics, bjork-shiley, medronic ats, st, jude medical mechanical valve or ionescu-shiley valve.Events of permanent pacemaker implant, complete heart block, mitral valve stenosis, valve dysfunction, valve thrombosis, structural valve deterioration, endocarditis, heart failure, heart transplant, stroke, myocardial dysfunction, cerebral hemorrhage, and reintervention 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: 11606537
• MDR Text Key: 243735800
• Report Number: 2648612-2021-00035
• 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: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 YR
• Patient Weight: 15