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

Model Number 25MJ-501

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Mitral Insufficiency (1963)

Event Date 12/04/2014

Event Type  Injury  

Event Description

In (b)(6) 2014, a double valve replacement procedure was performed due to aortic and mitral insufficiency.This 25 mm sjm masters series mechanical valve was implanted in the mitral position and a 21 mm sjm mechanical valve (model and s/n unknown) was implanted in the aortic position.It was reported the patient was compliant with anticoagulation.In (b)(6) 2014, the patient was hospitalized for mitral insufficiency.The mitral valve was considered restrictive due to the leaflets not opening and closing properly.Medical treatment was administered.It was reported there were no concerns or complaints regarding the 21 mm aortic mechanical valve.The patient was reported to be in stable condition.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis as it remains implanted.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with sjm specifications and procedures.Based on the information received, the cause of the reported incident could not be conclusively determined.

• 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 0072 5
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 0072 5
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 4369224
• MDR Text Key: 5233627
• Report Number: 2648612-2014-00056
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2019
• Device Model Number: 25MJ-501
• Device Catalogue Number: 25MJ-501
• Device Lot Number: 4539243
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2014
• 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: 48 YR
• Patient Weight: 51