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

Model Number 31M-101

Device Problems Backflow (1064); Perivalvular Leak (1457)

Patient Problems Chest Pain (1776); Dyspnea (1816); Hemolytic Anemia (2279); Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451)

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 case of takotsubo cardiomyopathy with paravalvular leakage and hemolytic anemia which occurred 31 years after mitral valve replacement", was reviewed.This research article reported a case study of a (b)(6) male, who was implanted with 31mm sjm prosthetic heart valve (mechanical heart valve) at the age of (b)(6), for mitral valve stenosis.It was noted that the patient developed atrial fibrillation developed at age (b)(6) and cerebrovascular infarction (ci) at age (b)(6).It was not mentioned in the literature whether occurrence of ci was related to mitral valve replacement (mvr).It was noted that the patient was in stable condition after mvr and no apparent symptom was observed during regular follow up.The measurement values of b-type natriuretic peptide (bnp), hemoglobin (hb) and lactate dehydrogenase (ldh) were being observed within acceptable range throughout the follow up (bnp: 50-70 pg/ml, hb: 10-11g/dl and ldh: 200-220 u/l).The day before hospitalization, the patient felt chest oppression and shortness of breath.The patient waited to see if the symptoms would improve.It did not improve, therefore the next day the patient visited the hospital.There was no abnormal findings in electrocardiogram (ecg) which had been conducted 3 month ago, negative t wave in 1-3 of chest leads was confirmed in ecg performed at admission.Bnp elevation (406 pg/ml) was observed and cardiac enlargement and pulmonary congestion were confirmed by a chest xp.The patient was hospitalized due to diagnosis of congestive heart failure.Because mild creatine phosphokinase (cpk) elevation was confirmed, emergent coronary angiogram (cag) was conducted.No significant stenosis was observed in coronary arteries.No spasm was confirmed by the provocation test.Akinesis from the mid portion of left ventricle to apex, and hyperkinesis of the base of left ventricle were observed by left ventriculography (lvg).Left ventricular ejection fraction (lvef) was 42%.There was no abnormal movement of the prosthetic valve leaflets under fluoroscopy though, mild mitral regurgitation and perivalvular regurgitation which had not been observed 6 month ago were detected.Takotsubo cardiomyopathy and mitral regurgitation associated with that were diagnosed in the end based on the image findings.Oxygen inhalation, administration of diuretic and nitrate were started.Pulmonary congestion improved within days.Bnp values also gradually improved.However perivalvular leakage remained.On the other hand, continuous elevation of ldh and deteriorated anemia (hb 7.0 g/dl) were observed.It was considered that progression of anemia was caused by mechanical hemolytic anemia, decline in function of hematopoiesis brought by deterioration in renal function.Transfusion of packed red blood cell and continuous erythropoietin administration were performed.The patient became in stable condition.After that, the patient was discharged from the hospital.The patient has been continuously put on medication in outpatient clinic and followed over 6 months, no recurrence of cardiac insufficiency has been observed at this moment.The mhv has remained implanted, mild mitral regurgitation has remained still though, the regurgitation has been considered not clinically significant so the patient has been continuously followed in outpatient clinic.[the primary and correspondence author of the article is bunju kaku, md, department of cardiology, toyama red cross hospital, 2 chome-1-58 ushijimahonmachi, toyama, 930-0859, japan].

Manufacturer Narrative

As reported in a research article, a 72 year old male was implanted with 31mm sjm prosthetic mechanical heart valve.Events of atrial fibrillation, cerebral infarction, chest oppression, shortness of breath, cardiac enlargement, pulmonary congestion, akinesis, hyperkinesis, mitral regurgitation, perivalvular regurgitation, anemia, and hematopoiesis 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
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12968832
• MDR Text Key: 286449623
• Report Number: 2648612-2021-00112
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 31M-101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/12/2022
• 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; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Male