MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, B.V. (CD) SJM MASTERS SERIES HEART VALVE W/TEFLON CUFF; HEART-VALVE, MECHANICAL

Model Number 25MTJ-503

Device Problems Sticking (1597); Structural Problem (2506)

Patient Problem Thrombus (2101)

Event Date 01/12/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2015, a double valve replacement was performed and this 25mm masters series mechanical heart valve was implanted in the mitral position and a 16mm non-sjm mechanical valve was implanted in the aortic position.On (b)(6) 2016, an echo revealed both leaflets of the 25mm mitral valve were stuck in the closed position and thrombus was suspected.The aortic valve continued to function without issue.A re-do mitral valve replacement was performed (b)(6) 2016.Ex vivo, significant thrombus was observed on the inflow side.A 23mm masters series mechanical heart valve was implanted.

Manufacturer Narrative

The results of this investigation concluded organizing thrombus was observed on the inflow and outflow surfaces of one of the leaflets which immobolized it.The other leaflet was freely mobile.Gram stains were negative for organisms.No evidence was found to suggest the cause of the thrombus formation was due to an intrinsic defect in the valve, as supported by review of the valve's device history record and the analysis performed.The cause of the reported event remains unknown.

• Brand Name: SJM MASTERS SERIES HEART VALVE W/TEFLON CUFF
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, B.V. (CD); lot 21; caguas west industrial park; caguas, puerto rico 00726 -099
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, B.V. (CD); lot 21; caguas west industrial park; caguas, puerto rico 00726 -099
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 5401242
• MDR Text Key: 37207717
• Report Number: 3003681312-2016-00003
• 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,Followup
• Report Date: 01/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/15/2018
• Device Model Number: 25MTJ-503
• Device Catalogue Number: 25MTJ-503
• Device Lot Number: 4079470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2013
• 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): Required Intervention
• Patient Age: 63 YR