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 Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2018

Event Type  Injury  

Manufacturer Narrative

The reported event of dislodged leaflets could not be confirmed.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; however, information from the field indicated that a smaller, 25mm, valve was subsequently implanted.Please note, per the instructions for use (b)(4) rev.A, "the valve should rotate freely.If resistance is noted, the valve holder/rotator may not be properly seated in the valve, the valve may not be in the fully closed position, or the valve may be oversized.If the valve does not rotate freely, do not force valve rotation.

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 this 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.

• 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: 8229703
• MDR Text Key: 132479662
• Report Number: 2648612-2019-00002
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734006460
• UDI-Public: 05414734006460
• 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: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/05/2021
• Device Model Number: 27MJ-501
• Device Catalogue Number: 27MJ-501
• Device Lot Number: 5631784
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2016
• 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