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

Model Number 27MJ-501

Device Problem Microbial Contamination of Device (2303)

Patient Problem Endocarditis (1834)

Event Date 11/26/2018

Event Type  Injury  

Manufacturer Narrative

An event of valve explant due to infective endocarditis was reported.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.Information from the field indicated that the patient had recently had a dental cavity.

Event Description

On (b)(6) 2012, a mitral valve replacement (mvr) was performed and this 27mm masters valve (model number: 27mj-501, serial number: (b)(4)) was implanted in the patient's mitral position.On (b)(6) 2018, re-do mvr was performed and this valve was explanted due to infective endocarditis (ie).During explant procedure, the patient's native mitral annulus was noted to have disrupted and the 27mm masters valve was about to be detached from the annulus.A second 27mm masters valve (model number: 27mj-501, serial number: (b)(4)) implanted in the mitral position; however, when the second 27mm masters valve was attempted to rotate using the holder handle, both leaflets dislodged from the valve.The second 27mm masters valve was explanted and the dislodged leaflets were entirely removed from the patient.A 25mm masters series mechanical heart valve (model number: 25mj-501, serial number: (b)(4)) was then implanted.The procedure was successfully completed without any further issues and the patient remained hemodynamically stable throughout the procedure.The patient's postoperative course was uneventful.Per the user, the procedure was extended.Per report the patient had a dental cavity prior to the initial mvr; however, the role in the development of ie and the need for explant was not confirmed "and" denied by the surgeon.As for the second operative procedure, it is reported that the operative field was not able to be wide and there was limited visibility which limited visibility and the limited visibility may have resulted in the holder handle not being firmly attached to the valve holder/rotator when the 27mm masters (2nd valve) was rotated.It is suspected that the leaflet dislodged was caused by the surgeon's handling.Patient specific information of patient's weight is not available for this complaint.

• 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 00725
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8196425
• MDR Text Key: 131406061
• Report Number: 2648612-2018-00105
• 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: 12/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2015
• Device Model Number: 27MJ-501
• Device Catalogue Number: 27MJ-501
• Device Lot Number: 3089403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/27/2018
• Initial Date FDA Received: 12/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2010
• 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: 61 YR