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

Model Number 29MJ-501

Device Problem Obstruction of Flow (2423)

Patient Problems Congestive Heart Failure (1783); Mitral Insufficiency (1963); Pleural Effusion (2010)

Event Type  Injury  

Manufacturer Narrative

The reported event of "prosthetic valve dysfunction" could not be confirmed.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

The following information comes from an abstract in the journal of japanese association for acute medicine (jjaam), volume28, no.9, sep 2017, p.516 (rp2-1) (available only in japanese), titled, a case of cardiac insufficiency approximately 20 years after mitral valve replacement for the treatment of mitral regurgitation.Approximately 20 years ago, a mitral valve replacement (mvr) was performed and this 29mm sjm mechanical heart valve (serial number unknown) was implanted in the patient's mitral position.Postoperatively, no symptoms of cardiac insufficiency were confirmed.About one week before the patient presented to the local clinic, a reduction in appetite and edema were reported.On an unknown date, edema and dyspnea worsened and the patient presented to a local clinic and then was taken to the emergency room.A chest x-ray revealed cardiac enlargement and bilateral pleural effusions.A brain natriuretic peptide (bnp) was reported to be 1128.8 ng/ml and congestive heart failure (chf) was diagnosed.There was no diuretic effect obtained with complete rest, supplemental oxygen and intravenous diuretic furosemide of 20mg/day.An echocardiogram was urgently performed and only one leaflet was shown in the mitral position.Furthermore, a cineradiography revealed that one of the leaflets was not opening and remained in the closed position.The patient was diagnosed with cardiac insufficiency due to prosthetic valve dysfunction.Warfarin was being administered and an international normalized ratio of prothrombin time (inr) was 3.62.An emergency surgical treatment was required and the patient was transferred to the department of cardiovascular surgery.There is no information available regarding the serial number of this valve, replacement device, implant/explant date of this valve or the patient's post-operative condition.Patient specific information of patient identifier, birthdate and weight are not available for this case.No further information is expected other than what was provided in this literature.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 7082558
• MDR Text Key: 93718351
• Report Number: 2648612-2017-00102
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 29MJ-501
• Device Catalogue Number: 29MJ-501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 84 YR