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

Model Number CVD0039

Device Problem Gradient Increase (1270)

Patient Problems Stenosis (2263); Obstruction/Occlusion (2422)

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.A review of the device history record was not possible since the serial number was unavailable.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

According to the article, a case of stuck valve in aortic position with sjm mechanical heart valve, from the journal of the japanese society of cardiovascular anesthesiologist, vol.22, suppl, 2017, p.239, 01-1-1, on an unknown date in 1992, a double valve replacement was performed due to combined valvular disease secondary to infective endocarditis in a petite patient.A 19mm sjm mechanical heart valve (mhv, model unknown) was implanted in the aortic position and a 25mm sjm mechanical heart valve was implanted in the mitral position.Per report, the patient was reported to have experienced dyspnea upon exertion since 2015.On an unknown date of (b)(6) 2016, edema in the lower extremities was observed and the patient¿s symptoms of heart failure worsened.A transthoracic echocardiography revealed left ventricular dimension diastolic/systolic (lvdd/ds) of 48/33mm and an ejection fraction of 60%.No abnormality in cardiac wall motion was noted.As severe aortic stenosis with a peak pressure gradient of 75 mmhg was confirmed, a re-do aortic valve replacement was scheduled for the treatment of prosthetic valve dysfunction.On an unknown date, an aortic valve replacement was performed.During explant, impeded mobility of one leaflet was seen on tee and the patient's peak pressure gradient was reported to be 240 mmhg under general anesthesia so it was presumed that the 19mm mhv was stuck in the closed position.Ex vivo, pannus was observed on the leaflet on the left coronary artery side and was suspected to have caused the leaflet to become stuck in the closed position.Per report, the closed leaflet was able to be manually opened and the mobility of the leaflets at the hinge in the recessed pivot area was normal.A 17mm sjm regent mechanical heart valve (model unknown) was implanted in the aortic position.The surgeon checked the function of the replacement valve and leaflet mobility on tee and the procedure was successfully completed with no issues.The 25mm mitral valve remains implanted.

• Brand Name: SJM MECHANICAL HEART VALVE (UNKNOWN)
• 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: 6921635
• MDR Text Key: 88405670
• Report Number: 2648612-2017-00081
• 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: 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: CVD0039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2017
• 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 Age: 79 YR
• Patient Weight: 48