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

Model Number MECJ-502

Device Problems Coagulation in Device or Device Ingredient (1096); Incomplete Coaptation (2507); Detachment of Device or Device Component (2907)

Patient Problems Hemorrhage/Bleeding (1888); Failure of Implant (1924); Thrombosis (2100)

Event Date 03/12/2019

Event Type  Injury  

Event Description

One of the mechanical valve leaflets detached from the valve: adult patient with congenital heart disease had mitral valve replacement with repeat sternotomy.Patient hemorrhaged overnight, but remained hemodynamically stable on low dose inotropic support and relatively stable pressor support receiving ongoing blood products.A limited echocardiogram on the next day demonstrated hemothorax and the decision was made to return to the operating room for evacuation of hematoma.Findings at surgery: excerpt from op note: transesophageal echocardiography demonstrated what appeared to be only one moving mitral valve leaflet with significant mitral regurgitation and flow reversal in the pulmonary veins.Additionally, there was a structure moving in the aortic root, which was interpreted as possible clot.On full ecmo support the aortic valve was not opening.Valve thrombosis was thought to be a possible cause for one of the leaflets to be stuck in the open position.Fluoroscopy was attempted on the operating room table in an attempt to better understand the valve dysfunction, however the dose of radiation and frame rate were insufficient to visualize the valve leaflets.The decision was made to return to bypass and take great care to avoid the heart ejecting and potentially embolizing the clot.On bypass, the aorta was cross-clamped and the aorta opened to directly give cardioplegia in the coronary ostia to avoid clot embolization.Surprisingly, a leaflet from the mitral valve prosthesis was sitting on the aortic valve leaflets.No clot was present.The aortic leaflets were normal in appearance.When the mitral valve was visualized, the prosthetic ring with all of the valve sutures was intact, however only one leaflet was present.This was re-replaced and the defect to the right atrium was again incorporated into the valve suture line near the "p3" region.

• Brand Name: SJM MASTERS SERIES
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 177 county road b e; saint paul MN 55117
• MDR Report Key: 8573028
• MDR Text Key: 143818099
• Report Number: 8573028
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/15/2019,03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MECJ-502
• Device Catalogue Number: 27MECJ-502
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/15/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 10220 DA
• Patient Weight: 96