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

Model Number	27MJ-501
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Valvular Insufficiency/ Regurgitation (4449)
Date of Event	06/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation results will be provided in the final report.
Event or Problem Description
Updated ed: it was reported that on (b)(6) 2021 a patient underwent an explant of their 27 mm, sjm masters series mechanical heart valve on (b)(6) 2021.The reason for the explant is unknown and the device (s/n (b)(4)) has been discarded and will not be returned for analysis.Three months later, on (b)(6) 2021, the patient required another re-do mitral valve replacement (mvr) and the second 27 mm, sjm masters series mechanical heart valve (s/n (b)(4)) was explanted.The need for explant three months post implant remains unknown, however.The patients pre-explant international normalized ratio (inr) was 3.4 units.Thrombus was found inside the leaflet hinge which appeared to be impeding the leaflets ability to open and close, causing the leaflets to stick.The patients condition may have also played a role.The second sjm masters series mechanical heart valve, (s/n (b)(4)) will be returning for analysis.A full multifaceted investigation has been requested from the implanting physician.No further information has been provided.Related manufacturer reference #2648612-2021-00068.
Additional Manufacturer Narrative
An event of cardiac arrest during procedure was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: SJM MASTERS SERIES MECHANICAL HEART VALVE
• Common Device Name: 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: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12118585
• Report Number: 3007113487-2021-00010
• Device Sequence Number: 3362162
• Product Code: LWQ
• UDI-Device Identifier: 05414734006460
• UDI-Public: 05414734006460
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/12/2022
• Device Model Number: 27MJ-501
• Device Catalogue Number: 27MJ-501
• Device Lot Number: 6134856
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2021
• Supplement Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 07/05/2021
• Supplement Report FDA Received Date: 11/11/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/13/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male