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

Model Number 31MJ-501

Device Problem Entrapment of Device (1212)

Patient Problem Death (1802)

Event Date 11/27/2013

Event Type  Injury  

Event Description

A patient underwent an aortic and mitral valve replacement procedure.After implanting the mitral valve, the leaflets were observed to be impeded.The physician rotated the valve and the impedance persisted.The mitral valve was removed and replaced with a non-sjm bioprosthesis resulting in a procedure delay.The physician believes the mechanical aortic valve that was implanted was affecting the leaflet function of the mitral valve.The patient expired thirty-five days following the procedure due to unknown causes.

Manufacturer Narrative

The results of this investigation indicated both leaflets were fully mobile with no surface damage to the valve components.No evidence was found to suggest there was an intrinsic defect in the valve, as supported by review of the valve's device history record and the analysis performed.It is unknown in this double valve replacement procedure which valve was implanted first, the aortic or the mitral.The cause of the reported immobile leaflets intraoperatively remains unknown.

• Brand Name: SJM MASTERS SERIES MECHANICAL HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL; caguas PR
• Manufacturer Contact: denise johnson, rn ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 4092316
• MDR Text Key: 4831109
• Report Number: 2648612-2014-00040
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2017
• Device Model Number: 31MJ-501
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/06/2013
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2012
• 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: 72 YR